[Translation] A randomized, open-label, two-sequence, four-period repeated crossover bioequivalence study of oral dydrogesterone tablets in Chinese healthy female subjects in the fasting and fed state

主要研究目的研究空腹和餐后状态下单次口服受试制剂地屈孕酮片（规格：10mg，浙江赛默制药有限公司生产）与参比制剂地屈孕酮片（商品名：达芙通®，规格：10mg，Abbott Biologicals B.V.生产）在中国健康女性受试者体内的药代动力学，评价两制剂生物等效性。次要研究目的评价中国健康女性受试者空腹和餐后单次口服受试制剂（T）地屈孕酮片和参比制剂（R）地屈孕酮片（达芙通®）后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation Dydrogesterone Tablets (Specification: 10 mg, produced by Zhejiang Thermo Pharmaceutical Co., Ltd.) and the reference preparation Dydrogesterone Tablets (trade name: Duphaston®, specification: 10 mg, produced by Abbott Biologicals B.V.) in healthy Chinese female subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations. Secondary study objectives To evaluate the safety of the test preparation (T) Dydrogesterone Tablets and the reference preparation (R) Dydrogesterone Tablets (Duphaston®) after a single oral administration in healthy Chinese female subjects after fasting and feeding.

Start Date14 Aug 2024

Sponsor / Collaborator

Gugel Pharmaceutical (Hainan) Co., Ltd.

CTR20242545 / CompletedNot Applicable

中国健康女性受试者空腹和餐后状态下口服地屈孕酮片的随机、开放、两序列、四周期重复交叉设计生物等效性试验

主要研究目的：研究空腹和餐后状态下单次口服受试制剂地屈孕酮片（规格：10mg，江苏和晨药业有限公司生产）与参比制剂地屈孕酮片（商品名：达芙通®，规格：10mg，Abbott Biologicals B.V.生产）在中国健康女性受试者体内的药代动力学，评价两制剂生物等效性。次要研究目的：评价中国健康女性受试者空腹和餐后单次口服受试制剂（T）地屈孕酮片和参比制剂（R）地屈孕酮片（达芙通®）后的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation Dydrogesterone Tablets (Specification: 10 mg, produced by Jiangsu Hechen Pharmaceutical Co., Ltd.) and the reference preparation Dydrogesterone Tablets (trade name: Daphaston®, specification: 10 mg, produced by Abbott Biologicals B.V.) in healthy Chinese female subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations. Secondary study objectives: To evaluate the safety of the test preparation (T) Dydrogesterone Tablets and the reference preparation (R) Dydrogesterone Tablets (Daphaston®) in healthy Chinese female subjects after a single oral administration in the fasting and fed state.

Start Date03 Aug 2024

Sponsor / Collaborator

Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd.

CTR20242295 / CompletedNot Applicable

地屈孕酮片人体生物等效性研究

[Translation] Study on the bioequivalence of dydrogesterone tablets in healthy volunteers

本试验旨在研究单次空腹和餐后口服广州朗圣药业有限公司研制、生产的地屈孕酮片（10 mg）的药代动力学特征；以Abbott Biologicals B.V.生产的地屈孕酮片（达芙通®，10 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of dydrogesterone tablets (10 mg) developed and produced by Guangzhou Langsheng Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Using dydrogesterone tablets (Duphaston®, 10 mg) produced by Abbott Biologicals B.V. as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

Start Date18 Jul 2024

Sponsor / Collaborator

Regenex Corp.

100 Clinical Results associated with Dydrogesterone

100 Translational Medicine associated with Dydrogesterone

100 Patents (Medical) associated with Dydrogesterone

743

Literatures (Medical) associated with Dydrogesterone

31 Dec 2024·GYNECOLOGICAL ENDOCRINOLOGY

Statement of Retraction: Luteal support with vaginal dydrogesterone increases pregnancy rate in patients with clomifene resistant polycystic ovary syndrome receiving letrozole for ovulation induction

31 Dec 2024·GYNECOLOGICAL ENDOCRINOLOGY

Ultra-low-dose continuous combined estradiol and dydrogesterone in postmenopausal women: A pooled safety and tolerability analysis

Article

Author: Kahler, Elke ; Ren, Mulan ; Graziano Custodio, Marcelo ; Stevenson, John C. ; Simoncini, Tommaso ; Yu, Qi ; Nappi, Rossella E. ; Karpova, Viktoriya ; Tatarchuk, Tetiana

Objective: To assess the safety and tolerability of ultra-low dose estradiol and dydrogesterone (E0.5 mg/D2.5 mg) among postmenopausal women. Methods: This pooled analysis of data from three clinical studies assessed the effects of continuous combined ultra-low-dose estradiol and dydrogesterone among postmenopausal women. Participants received E0.5 mg/D2.5 mg or placebo for 13 weeks (double-blind, randomized, European study), E0.5 mg/D2.5 mg or placebo for 12 weeks (double-blind, randomized, Chinese study), or E0.5 mg/D2.5 mg for 52 weeks (open-label, European study). Safety outcomes included treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment discontinuation due to a TEAE, and adverse events of special interest (AESIs). Results: Overall, 1027 women were included in the pooled analysis (E0.5 mg/D2.5 mg, n = 736; placebo, n = 291). Mean treatment exposure was 288.9 days in the E0.5 mg/D2.5 mg group and 86.6 days in the placebo group. The proportion of women experiencing ≥1 TEAE was similar in the E0.5 mg/D2.5 mg and placebo groups (50.1% vs 49.5%, respectively). TESAEs occurred in 12 (1.6%) women receiving E0.5 mg/D2.5 mg and 9 (3.1%) women receiving placebo. Discontinuation of study treatment was infrequent in both groups (E0.5 mg/D2.5 mg: 1.5%; placebo: 2.4%). The occurrence of breast pain was more common in the E0.5 mg/D2.5 mg group than in the placebo group (2.0% vs 0.3%) as was uterine hemorrhage (6.5% vs 2.4%). The incidence of acne, hypertrichoses and weight increased was similar between groups. Conclusions: Across three studies, ultra-low-dose estradiol plus dydrogesterone was well tolerated among postmenopausal women, with no increase in TEAEs or TESAEs compared with placebo.

31 Dec 2024·Journal of medical economics

Evaluating the cost utility of estradiol plus dydrogesterone for the treatment of menopausal women in China

Article

Author: Graziano, Custodio Marcelo ; Downes, Martin ; Yu, Qi ; Tamlyn Anne, Rautenberg ; Ren, Mulan ; Wang, Yaping ; Simoncini, Tommaso ; Kim, Kyoo

AIM:

Evaluate the cost utility of menopausal hormone therapy for women in China.

MATERIALS AND METHODS:

A bespoke Markov cost utility model was developed to evaluate a cohort of symptomatic perimenopausal women (>45 years) with intact uterus in China in accordance with China's Pharmacoeconomic guideline. Short (5-year) and long (10-year) treatment durations were evaluated over a lifetime model time horizon with 12-month cycle duration. Societal and healthcare payer perspectives were evaluated in the context of a primary care provider/prescriber, outpatient setting with inpatient care for patients with chronic conditions. Disease risk and mortality parameters were derived from focused literature searches, and China Diagnosis-related Group cost data was included. Comprehensive scenario, univariate and probabilistic sensitivity analysis were undertaken along with independent validation. This is the first model to include MHT-related disease risks.

RESULTS:

According to base case results, the total cost for MHT was 22,516$ (150,106¥) and total quality adjusted life years 12.32 versus total cost of no MHT 30,824$ (205,495¥) and total quality adjusted life years 11.16 resulting in a dominant incremental cost effectiveness ratio of -7,184$ (-47,898¥) per QALY. Results hold true over a range of univariate deterministic sensitivity and scenario analyses. Probabilistic analysis showed a 91% probability of being cost effective at a willingness to pay threshold of three times Gross Domestic Product per capita in China.

CONCLUSION:

Contingent on the structure and assumptions of the model, combination of estradiol plus dydrogesterone MHT is potentially cost saving in symptomatic women over the age of 45 years in China.

News (Medical) associated with Dydrogesterone

04 Jul 2024

·www.pharmaceutical-technology.com

Viatris closes $3.37bn divestitures with OTC deal

Viatris completed the last of its $3.37bn divestitures, signing a deal with Cooper Consumer Health to transfer of its OTC business. Credit: SOPA Images via Getty Images. Viatris announced the finalisation of a transaction to divest its over-the-counter (OTC) business, completing the last step in its previously declared $3.37bn divestitures. The US-headquartered company divested its entire OTC business to Cooper Consumer Health, a European OTC drug manufacturer, on 3 July. In the agreement, Cooper Consumer Health has gained access to two manufacturing plants based in Merignac, France; and Confienza, Italy, and a research and development site in Monza, Italy. In its strategic plan, Viatris retained the rights for its blockbuster generic drugs Viagra (sildenafil) and Dymista (azelastine hydrochloride and fluticasone propionate) alongside certain other OTC therapies. Viatris first spread word of the OTC divestiture in October 2023 declaring definitive agreements to divest other areas of the company. Over the last few months, the nutraceutical company Matrix Pharma Private gained access to Viatris’ active pharmaceutical ingredients division and Spanish pharmaceutical company Insud Pharma acquired Viatris’ women’s health business. The latter deal gave Insud Pharma two manufacturing plants in India. Furthermore, a December 2023 definitive agreement transferred Viatris’ European rights for therapies such as Duphaston (Dydrogesterone) and Femoston (estradiol) to Theramex . The generics company also divested commercialisation rights in some non-core markets that were acquired, when Viatris was formed through the combination of Mylan and UpJohn. As per a 3 July press release, Viatris made the various divestitures to help achieve its “long-term gross leverage target” and “increase shareholder return through share buybacks and dividends”. The generics company also plans to use the money to acquire, develop and commercialise more therapies in the future. Last year, the company generated a total revenue of $15.4bn, reaching a free cash flow of $2.4bn. By 28 January 2024, the company had already completed $250m in share repurchases for this year. See Also: Left in limbo: When pharma halts rare disease research The pathway to preventative health: How pharma can support the NHS Long Term Plan In November 2022, Viatris released a strategic update detailing a two-stage plan for business growth with plans to end Phase I by the end of this year and execute Phase II between 2024 and 2028. In the first phase, the company aimed to complete all planned divestitures, have seven consecutive quarters of strong performance and continue progress on key science programmes among other things. At the January 2024 JP Morgan Healthcare Conference, Viatris announced that it had achieved its goals for Phase I and will be advancing to Phase II, which prioritises the growth of the company’s ophthalmology division and prevention of base business erosion.

AcquisitionPhase 2

03 Jul 2024

·www.prnewswire.com

Viatris Brings to Completion All Previously Announced Divestitures With the Closing of its Over-the-Counter Business Divestiture

Achievement of This Major Milestone Further Simplifies and Strengthens the Company and Positions Viatris to Achieve its Key Priorities and Accelerate Future Growth PITTSBURGH, July 3, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced that it has closed the divestiture of its Over-the-Counter (OTC) business to Cooper Consumer Health, a leading European over-the-counter drug manufacturer and distributor, bringing to substantial completion all previously announced divestitures. In October, the Company announced it had entered into agreements to divest substantially all of its OTC business, as well as its Women's Healthcare business, its Active Pharmaceutical Ingredients (API) business in India and commercialization rights in certain non-core markets. The completion of the OTC divestiture, the largest of the divestitures that the Company previously announced, is a major milestone in the execution of the Company's strategic plan to considerably simplify the organization in order to increase focus on areas with the greatest potential to accelerate growth, patient impact and shareholder value. The Company believes it found the right fit and future owners for all these well-performing businesses and has been committed to ensuring a successful transition for colleagues, partners, customers and patients. The Company reiterated that the proceeds from its divestitures and its sector-leading cash flow generation gives it line of sight to achieving its key priorities, including: achieving its long-term gross leverage target, increasing shareholder return through share buybacks and dividends, fueling its base business and, importantly, making disciplined, strategic investments to identify, acquire, develop and commercialize innovative assets that can build off its very strong base business and drive future revenue growth. "Closing the divestiture of our OTC business is a significant milestone in the execution of our strategic plan," said Scott A. Smith, Chief Executive Officer, Viatris. "With all our previously announced divestitures now substantially complete, Viatris is stronger and more streamlined. We look forward to an exciting future in which we continue to build on our very strong base business and add to our innovative product pipeline to drive strong future revenue growth and positively affect even more patients' lives worldwide." Divestitures Summary Viatris divested substantially all of its OTC business to Cooper Consumer Health, a leading European over-the-counter drug manufacturer and distributor. The transaction includes two manufacturing sites located in Merignac, France, and Confienza, Italy, and a Research & Development site in Monza, Italy. The Company is retaining rights for Viagra®, Dymista® and select OTC products in certain markets. The transaction closed on July 3, 2024. Viatris previously announced that it has divested its API business in India to Matrix Pharma Private Limited. The transaction includes three manufacturing sites and an R&D lab in Hyderabad, three manufacturing sites in Vizag and third-party API sales. Viatris is retaining some selective R&D capabilities in API. The transaction closed in June 2024. Viatris previously announced that it has divested its Women's Healthcare business, primarily related to oral and injectable contraceptives, to Insud Pharma, a leading Spanish multinational pharmaceutical company. The transaction includes two manufacturing facilities in India: one in Ahmedabad and one in Sarigam. The transaction closed in March 2024. Separately, in another transaction, Viatris previously announced it has divested its rights to women's healthcare products Duphaston® and Femoston® in certain countries to Theramex HQ UK Limited, a leading global specialty pharmaceutical company dedicated to women's health. The transaction (other than in the U.K., which remains subject to regulatory approval) closed in December 2023. As previously indicated, Viatris' next update with respect to 2024 financial guidance will reflect the impact of the OTC divestiture, including adjustments to exclude the expected performance of the OTC business from the closing date of the transaction through the end of 2024. About Viatris Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements that achievement of this major milestone further simplifies and strengthens the Company and positions Viatris to achieve its key priorities and accelerate future growth; the completion of the OTC divestiture is a major milestone in the execution of the Company's strategic plan to considerably simplify the organization in order to increase focus on areas with the greatest potential to accelerate growth, patient impact and shareholder value; the Company believes it found the right fit and future owners for all these well-performing businesses and has been committed to ensuring a successful transition for colleagues, partners, customers and patients; the proceeds from its divestitures and its sector-leading cash flow generation gives it line of sight to achieving its key priorities, including: achieving its long-term gross leverage target, increasing shareholder return through share buybacks and dividends, fueling its base business and, importantly, making disciplined, strategic investments to identify, acquire, develop and commercialize innovative assets that can build off its very strong base business and drive future revenue growth; we look forward to an exciting future in which we continue to build on our very strong base business and add to our innovative product pipeline to drive strong future revenue growth and positively affect even more patients' lives worldwide; as previously indicated, Viatris' next update with respect to 2024 financial guidance will reflect the impact of the OTC divestiture, including adjustments to exclude the expected performance of the OTC business from the closing date of the transaction through the end of 2024. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; the possibility that Viatris may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that Viatris may be unable to achieve intended or expected benefits, goals, outlooks, synergies, growth opportunities and operating efficiencies in connection with divestitures, acquisitions, other transactions or restructuring programs, within the expected timeframes or at all; goodwill or impairment charges or other losses related to the divestiture or sale of businesses or assets; Viatris' failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. SOURCE Viatris Inc.

Acquisition

10 Oct 2023

·www.biospace.com

Theramex Announces Agreement to Acquire the European Rights to Duphaston® and Femoston® From Viatris, Inc.

LONDON--(BUSINESS WIRE)-- Theramex, a leading global speciality pharmaceutical company dedicated to women’s health, is pleased to announce that it has entered into an agreement to acquire the European rights to Duphaston® and Femoston® from Viatris Inc. Viatris retains the rights for Australia and Japan. The transaction is subject to customary regulatory and anti-trust approvals. “As we continue to strengthen our commitment to women’s health and improve our patients access to high quality treatments, we are excited to acquire new products to expand our Menopause portfolio.” - Rob Stewart, CEO of Theramex. Duphaston® (dydrogesterone) and Femoston® (estradiol/dydrogesterone) may be prescribed in indications related to hormone replacement therapy (HRT). About Theramex Theramex is a leading, global specialty pharmaceutical company dedicated to women and their health. With a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis, Theramex supports women at different stages of their lives. Our vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing innovative, effective solutions that care for and support women as they advance through each stage of their lives. To learn more about Theramex, please visit . View source version on businesswire.com: Contacts For further information about Theramex, please contact: Katja Lundell, Senior Director, Global Head of Policy, Pricing and Communications. Email: Katja.Lundell@theramex.com Phone : +44 203 962 5555 THX_HQ_PRESSR_011393 Source: Theramex View this news release online at:

License out/inDrug Approval

100 Deals associated with Dydrogesterone

External Link

KEGG	Wiki	ATC	Drug Bank
D01217	Dydrogesterone	G03DB01	DB00378

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Uterine Hemorrhage	CN	Abbott Healthcare Products BV	31 Dec 2002
Abortion, Habitual	JP	Viatris Pharmaceutical GK	31 Oct 1964
Abortion, Threatened	JP	Viatris Healthcare GK	31 Oct 1964
Amenorrhea	JP	Viatris Pharmaceutical GK	31 Oct 1964
Dysmenorrhea	JP	Viatris Pharmaceutical GK	31 Oct 1964
Infertility	JP	Viatris Pharmaceutical GK	31 Oct 1964
Metrorrhagia	JP	Viatris Pharmaceutical GK	31 Oct 1964
Endometriosis	GB	Solvay SA	01 Jan 1961
Menstruation Disturbances	GB	Solvay SA	01 Jan 1961

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Phase 3	AT	Alere, Inc.	01 Aug 2013
Infertility, Female	Phase 3	BE	Alere, Inc.	01 Aug 2013
Infertility, Female	Phase 3	FI	Alere, Inc.	01 Aug 2013
Infertility, Female	Phase 3	DE	Alere, Inc.	01 Aug 2013
Infertility, Female	Phase 3	IL	Alere, Inc.	01 Aug 2013
Infertility, Female	Phase 3	RU	Alere, Inc.	01 Aug 2013
Infertility, Female	Phase 3	ES	Alere, Inc.	01 Aug 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03858049 (CTgov)	Phase 4	Infertility	172	Crinone	kptoikpgph(uneqwnahtt) = ebjibzlkka kmavkmpcwh (tchtuzdkxc, npnbwzdmbq - tmqjbekklt) View more	-	11 Mar 2024
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Combined Oral Contraceptive+Decapeptyl+Cyclo-Progynova+progesterone+Gonadotropin+Duphaston (the Progestin Primed Double Stimulation Group)	xzroxbsqpg(hxifkezivy) = abcpodiotb wtndowdvfm (lxfgiuakli, koqknelcfe - hddhcvvduc) View more	-	17 Feb 2022
				Combined Oral Contraceptive+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone+Chorionic Gonadotropin+Gonadotropin (the Flexible GnRh Antagonist)	itlzjjebms(oepsclpfql) = jivevdanxa thgppzofon (ifwuodvxjg, howsjrjygt - vmsqnbwadq) View more
NCT03935152 (Pubmed \| BMC Pregnancy Childbirth)	Phase 4	Obstetric Labor, Premature	48	Oral dydrogesterone 10mg	swtfgxlijt(fweunemfmz) = bofadjbovg sbbcfcxpvc (aivbfufqqq )	Negative	28 Jan 2021
				Placebo	swtfgxlijt(fweunemfmz) = gdxvprkkvc sbbcfcxpvc (aivbfufqqq )
NCT02491437 (Lotus II, CTgov)	Phase 3	Infertility, Female	1,034	Dydrogesterone 30 mg (Dydrogesterone Tablets 3x10 mg)	fedtqudfpd(pktefgyfez) = wewfuzugai dajofhchag (lqzdslvcmm, xdmaqflnly - ftzoxtexra) View more	-	01 Oct 2019
				intravaginal progesterone gel 90 mg (Crinone 8% Intravaginal Progesterone Gel 90 mg)	fedtqudfpd(pktefgyfez) = bjwumttpzw dajofhchag (lqzdslvcmm, unhlxnnvvy - ljodkxxrhb) View more
NCT02491437 (Lotus II, Pubmed)	Phase 3	Ventricular Fibrillation, Paroxysmal Familial, 1	1,034	Oral dydrogesterone 30 mg	tmglrwyhxt(rriutliezw) = pndvzodxht fsojcideoz (mleqrmmpdm ) View more	Positive	01 Dec 2018
				8% MVP gel 90 mg	tmglrwyhxt(rriutliezw) = zisjcnmwug fsojcideoz (mleqrmmpdm ) View more
NCT01850030 (Lotus I, CTgov)	Phase 3	Infertility, Female	1,070	Placebo progesterone+Dydrogesterone 30 mg (Dydrogesterone 30 mg)	zsquojwblr(qgemajcdql) = lddlcgarbh nislifwqib (guucvwwsmu, fihkdirgxm - gbyvdojevk) View more	-	02 Jan 2018
				Placebo dydrogesterone+Micronized Progesterone 600 mg (Micronized Progesterone 600 mg)	zsquojwblr(qgemajcdql) = ntipesalev nislifwqib (guucvwwsmu, pjlrcswcar - hffjaocyfk) View more
ChiCTR-IOR-15007265 (Pubmed \| Fertil Steril)	Not Applicable	Infertility	250	Duphaston	xhpbtptghy(nzkevrdwtn) = ufebryyimx blpvdrxgxi (gqkymioqhi ) View more	-	01 Sep 2017
				Utrogestan	xhpbtptghy(nzkevrdwtn) = fyjhrzfvbq blpvdrxgxi (gqkymioqhi ) View more
NCT01850030 (Lotus I, Pubmed \| Hum Reprod)	Phase 3	-	1,031	Oral dydrogesterone 30 mg daily	zfzyozqmrm(jzulclgxzm) = lyisiawzjm faxomkgelw (rpxfutakbi ) View more	Positive	01 May 2017
				Micronized vaginal progesterone 600 mg daily	zfzyozqmrm(jzulclgxzm) = cokqgjcwfy faxomkgelw (rpxfutakbi ) View more
NCT03935152 (Pubmed \| Sci Rep)	Phase 4	Obstetric Labor, Premature Adjuvant	48	Oral dydrogesterone (20mg daily)	(zjknfuusqf) = dnedpudazx msjmfldvgn (flexqwedmu ) View more	Negative	09 Feb 2016
				Oral placebo	(zjknfuusqf) = fkvtbpvbfg msjmfldvgn (flexqwedmu ) View more
NCT01178931 (Pubmed \| Eur J Obstet Gynecol Reprod Biol)	Not Applicable	-	853	Crinone 8% vaginal progesterone gel	upfasuikzr(ykkyfhqxmt) = Interference with coitus occurred significantly more in Crinone group than in dydrogesterone group hmumeiduda (kghzncwdcv ) View more	-	01 Mar 2015
				Oral dydrogesterone Duphaston

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