本试验旨在研究单次空腹和餐后口服浙江仙琚制药股份有限公司研制、生产的炔雌醇环丙孕酮片（炔雌醇0.035 mg + 醋酸环丙孕酮2 mg）的药代动力学特征；以Bayer Weimar GmbH und Co. KG生产的炔雌醇环丙孕酮片（达英-35®，炔雌醇0.035 mg + 醋酸环丙孕酮2 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 a single fasting and postprandial oral administration of ethinyl estradiol cyproterone acetate tablets (0.035 mg ethinyl estradiol + 2 mg cyproterone acetate) developed and produced by Zhejiang Xianjun Pharmaceutical Co., Ltd.; using ethinyl estradiol cyproterone acetate tablets (Diane-35®, 0.035 mg ethinyl estradiol + 2 mg cyproterone acetate) produced by Bayer Weimar GmbH und Co. KG as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.

Start Date26 Feb 2024

Sponsor / Collaborator

Zhejiang Xianju Pharmaceutical Co., Ltd.

NCT05657171

/ CompletedNot ApplicableIIT

"Effect of Cyproterone Acetate / Ethinyl Estradiol Combination on Periodontal Tissue and High Sensitivity C- Reactive Protein Levels in Women With Polycystic Ovary Syndrome Having Gingivitis."

PCOS is a widely reported condition among young female population and anti-androgen agents are increasingly being used as part of the medical management of such cases. However, Clinical studies have reported higher prevalence of gingival inflammation, loss of attachment and gingival enlargement in women taking hormone based oral contraceptives. Additionally, CPA has been reported to have an osteoclastic action. Therefore, it is necessary to explore the effects of these medications on the periodontal condition of PCOS patients having gingivitis, who already are pre-disposed to systemic inflammation. Therefore, the present study aims to longitudinally evaluate the effect of CPA/EE combination regimen on the periodontal status of female patients diagnosed with PCOS with pre-existing gingivitis..

Start Date12 Dec 2022

Sponsor / Collaborator

Postgraduate Institute of Dental Sciences Rohtak

NCT05316935

/ RecruitingPhase 2/3IIT

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment

To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.

Start Date13 Jul 2022

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Cyproterone Acetate/Ethinylestradiol

100 Translational Medicine associated with Cyproterone Acetate/Ethinylestradiol

100 Patents (Medical) associated with Cyproterone Acetate/Ethinylestradiol

362

Literatures (Medical) associated with Cyproterone Acetate/Ethinylestradiol

01 Feb 2025·Journal of Ethnopharmacology

Treatment of Qin Gui Wan (QGW) in PCOS abnormal oocytes development via AMPK/PGC-1ɑ pathway

Article

Author: Cui, Yiwei ; Zhang, Shujing ; Zhang, Chuxin ; Cheng, Yuli ; Yang, Chenyu ; Gao, Lin ; Li, Xiaojuan ; Yu, Xue ; Zang, Weiyu

OBJECTIVESTo investigate the therapeutic effects of Qin Gui Wan (QGW) and its disassembled functional drug groups, Wenyang Zhuhuo (WYZH) and Xinwen Zhuyang (XWZY), on letrozole-induced PCOS rats.METHODSPCOS rat model was established by administering letrozole for 21 days. The rats were divided into control, PCOS, Diane-35, QGW, WYZH and XWZY groups. The changes of body weight, ovarian coefficient, estrous cycle and sex hormone levels were observed. The ovarian histological characteristics and ovulation were observed by HE staining. P450arom, SF-1, and AMPK/PGC-1ɑ pathway mRNA and protein expression were analyzed using qRT-PCR, WB, and IHC. The AMPK inhibitor Compound C (CC) was used to explore the treatment mechanism of QGW in granulosa cells. And UHPLC-MS/MS was used to performed chemical composition analysis.RESULTSQGW, WYZH, and XWZY can correct the disordered estrous cycle of PCOS rats and improve the serum hormone status of rats to varying degrees. HE results indicated that QGW, WYZH, and XWZY improved ovarian polycystic changes and normalized ovulation. qRT-PCR, WB, and IHC results demonstrated that QGW, WYZH, and XWZY increased PGC-1α, SF-1, and P450arom mRNA and protein expression in the ovaries of PCOS rats. The level of AMPK mRNA in the ovaries of QGW and its disassembled prescriptions increased, while only WYZH and XWZY rats showed increased ovarian AMPK levels. CC attenuated the activation of AMPK, PGC-1α, SF-1, and P450arom mRNA by QGW.CONCLUSIONSThis study demonstrates that QGW alleviates abnormal oocyte development in PCOS rats, possibly by enhancing P450arom expression via the AMPK/PGC-1α pathway, thus restoring normal androgen-estrogen balance and follicular development.

31 Dec 2024·Gynecological Endocrinology

Comparative effects of the antioxidant glutathione with metformin and Diane-35 on hormonal, metabolic, and inflammatory indicators in a DHEA-induced PCOS rat model

Article

Author: Timur, Hikmet Tunç ; Tanoglu, Fatma Basak ; Özkara, Gülçin ; Tok, Olgu Enis ; Çetin, Çağlar ; Coşar, Aslı ; Neccar, Duygu ; Özcan, Pınar

OBJECTIVEComparison of hormonal, metabolic and inflammatory markers of glutathione with metformin and Diane-35 in a rat model of PCOS induced by dehydroepiandrosterone.METHODSTwenty-five female rats were randomized into four groups. Group 1 was administered a subcutaneous dose of 0.2 ml saline/day. Group 2 was given 0.2 ml of 1% carboxymethyl cellulose (CMC)/day orally for 28 days. A PCOS model was established with DHEA in rats. Group 3 was given 4.5 mg/kg/day of Diane-35 orally dissolved in 1% CMC for 28 days. Group 4 was given 300 mg/kg/day of metformin orally dissolved in 1 ml of saline for 28 days, and Group 5 was administered 100 mg/kg of glutathione intraperitoneally on days 35, 42, and 49. On day 56, the rats were sacrificed. Serum markers and follicle count were examined.RESULTSSerum IL-6, hs-CRP, insulin, testosterone, SHBG, and MDA values were significantly lower in the glutathione group than in the PCOS group (p = 0.0006, p = 0.023, p = 0.0082, p = 0.0007, p = 0.0048, and p < 0.0001, respectively).The number of all follicles was similar between the control and glutathione groups (p < 0.05). When we compared the other groups with the PCOS group, the number of primary, secondary, atretic, and cystic follicles was significantly lower in the metformin and glutathione groups. The number of primordial and antral follicles was significantly higher than in the PCOS group.CONCLUSIONSGlutathione plays anti-inflammatory and antioxidant roles, similar to metformin, by lowering serum IL-6, insulin, testosterone, CRP, and MDA levels; decreasing atretic/cystic follicle count; and improving antral follicle count and folliculogenesis in PCOS patients.

01 Sep 2024·Heliyon

Efficacy and safety of cangfu daotan decoction as an adjuvant treatment of Diane-35 for polycystic ovary syndrome: A systematic review and meta-analysis

Article

Author: Xu, Sheng ; Cheng, Shaomin ; Feng, Xianjie ; Chen, Xin ; Zhou, Xu

ObjectiveCangfu Daotan decoction is a classic traditional Chinese medicine formula that has been found to be beneficial for treating polycystic ovarian syndrome (PCOS) in animal models. This systematic review aimed to assess the efficacy and safety of Cangfu Daotan decoction as an adjuvant treatment to Diane-35 for PCOS in humans.MethodsSeven electronic databases were searched up to June 22, 2024, to identify randomized controlled trials (RCTs) that evaluated Cangfu Daotan decoction combined with Diane-35 versus Diane-35 alone for the treatment of PCOS. The effects of individual RCTs were combined via meta-analysis and were measured as relative risks (RRs) or weighted mean differences (WMDs).ResultsTwenty-five RCTs with a moderate to high risk of bias were included, involving 1845 patients with PCOS. Meta-analyses indicated that compared with Diane-35 alone, the combination of Diane-35 and Cangfu Daotan decoction significantly improved the response rate (RR 1.19, 95 % confidence interval [CI] 1.14 to 1.24), pregnancy rate (RR 1.57, 95 % CI 1.18 to 2.09), ovulation rate (RR 1.22, 95 % CI 1.11 to 1.35), and ovarian volume (WMD -1.43 cm³, 95 % CI -2.46 to -0.39). Cangfu Daotan decoction also significantly reduced the luteinizing hormone (LH) level, LH:FSH ratio, testosterone level, prolactin level, body mass index (BMI) and hirsutism and acne scores but had no significant effect on the follicle-stimulating hormone (FSH) level. All adverse events were mild and not related to Cangfu Daotan decoction treatment.ConclusionsThe findings suggest that Cangfu Daotan decoction, as an adjuvant therapy to Diane-35 for the treatment of PCOS, can reduce multiple sex hormone levels and BMI, relieve hyperandrogenism signs, and ultimately improve pregnancy outcomes, with good safety. The effect of Cangfu Daotan decoction on FSH remains uncertain. Due to limitations of risk of bias and heterogeneity, the quality of evidence was rated as moderate to very low.

100 Deals associated with Cyproterone Acetate/Ethinylestradiol

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R&D Status

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Indication	Country/Location	Organization	Date
Acne Vulgaris	China	Bayer Vital GmbH	20 Aug 2004
Hirsutism	China	Bayer Vital GmbH	20 Aug 2004
Prostatic Cancer	China	Bayer Vital GmbH	20 Aug 2004
Puberty, Precocious	China	Bayer Vital GmbH	20 Aug 2004

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04964193 (CTgov)	Not Applicable	-	24	Elzsa film-coated tablet (Elzsa Film-coated Tablet)	izdgstkmyo(thjeefcnft) = mvypdmlfdh jjqhfyfocz (afskixitdp, ihuiambivx - yercomsybn) View more	-	31 Jan 2022
				Diane-35 Sugar-coated tablet (Diane-35 Sugar-coated Tablet)	izdgstkmyo(thjeefcnft) = lndackcoyp jjqhfyfocz (afskixitdp, wzjqtyvxwu - qizydwghdu) View more

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