An Open-Label Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility criteria.

Start Date26 Jul 2016

Sponsor / Collaborator

Repros Therapeutics, Inc.

NCT02651688 / CompletedPhase 2

A Randomized, Double Blind, Placebo-Controlled, Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene

The purpose of this study is to compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters in overweight men with acquired hypogonadotropic hypogonadism [confirmed morning testosterone (T) ≤300 ng/dL] following a 6 month diet and 15 month exercise program.

Start Date11 Jan 2016

Sponsor / Collaborator

Repros Therapeutics, Inc.

NCT02301897 / CompletedPhase 2

A Phase 2, Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

The primary objective of this study is to determine the safety and efficacy of two oral doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.

Start Date16 Mar 2015

Sponsor / Collaborator

Repros Therapeutics, Inc.

100 Clinical Results associated with Repros Therapeutics, Inc.

0 Patents (Medical) associated with Repros Therapeutics, Inc.

Literatures (Medical) associated with Repros Therapeutics, Inc.

01 Sep 2014·Fertility and SterilityQ2 · MEDICINE

Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone

Q2 · MEDICINE

Article

Author: Nydell, Jennifer ; Hsu, Kuang ; Fontenot, Gregory K ; Wiehle, Ronald D ; Lipshultz, Larry ; Wike, Jenny

OBJECTIVETo determine the effect of enclomiphene citrate in men with secondary hypogonadism.DESIGNPhase II clinical trial.SETTINGCommunity dwelling men making visits to physician offices.PATIENT(S)Men with secondary hypogonadism.INTERVENTION(S)Oral administration of enclomiphene citrate or 1% topical T gel.MAIN OUTCOME MEASURE(S)Luteinizing hormone, FSH, T, and semen analysis.RESULT(S)Treatment with enclomiphene citrate resulted in increased morning serum T, E2, and LH levels similar to those obtained with a topical T gel in men with secondary hypogonadism. Follicle-stimulating hormone and LH were increased with enclomiphene, and sperm counts were conserved.CONCLUSION(S)Enclomiphene citrate reverses the two hallmarks of secondary hypogonadism, namely, low serum total T and low or inappropriately normal LH while preserving sperm production.CLINICAL TRIAL REGISTRATION NUMBERNCT01270841 (ClinicalTrials.gov Identifier NCT01270841).

15 Apr 2013·Cancer Research

Abstract 5670: In vitro and in vivo transdermal delivery of CDB4124, a progesterone receptor modulator: a potential method for breast cancer prevention .

Author: Lee, Oukseub ; Shidfar, Ali ; Khan, Seema A. ; Ivancic, David ; Wiehle, Ronald

AbstractBackground: CDB4124 a progesterone receptor modulator suppressed the development of precancerous lesions and carcinogen-induced ER+ mammary tumors in rats, and may have implications for prevention and treatment of human breast cancer; however liver toxicity in human is the major problem of systemic delivery, and transdermal local delivery to the breast may be an excellent solution. We tested transdermal CDB4124 for in vitro human skin permeation and in vivo tissue distribution in rats compared to s.c delivery.Methods: We tested CDB4124 (Repros Therapeutics, Inc.) alone and with ethanol and 0.5 v/v % oleic acid (OA) using split-thickness skin from mastectomy specimens, mounted in Franz diffusion cells (PermeGear, PA, USA), 0.5mg of CDB4124 in 60 % alcoholic solution +/- OA and applied to the donor chamber. Aliquots of the receiver solution were collected at pre-determined time points for 24 hr. Next, we tested the in vivo permeation of gel formulation of CDB4124 + 0.5% OA in nude rats comparing daily transdermal delivery (0.3mg/day) with a s.c pellet (30mg) for 6 weeks. Plasma and mammary fat pads(MFPs) were collected. CDB4124 and its major metabolite CDB4453 were quantified by LC-MS/MS.Results: The permeation through human breast skin was 3.1± 0.9% for CDB4124 alone and enhanced 4-fold to 11.6±1.5% with the addition of 0.5% OA at 24 hr. The rate of CDB4124 permeation was 5-fold faster than the drug alone within 12 hr. Plasma levels of CDB4124 were 14±5 and 11±5 ng/mL for the pellet and gel groups, respectively (p= 0.16); plasma level of CDB4453 was higher in the pellet group than in the gel group, 4.6±2 vs. 1.5±0.6 ng/mL (p=0.000). CDB4124 levels in the upper MFP (the site of gel application) were 34-fold higher in the gel group than in the pellet group (1485ng/g for gel group; 44ng/g for pellet group, p=0.000); CDB4124 levels in the lower MFP were 194 ng/g for gel group; 66 ng/g for pellet group. CDB4124 and CDB4453 levels in upper MFP were significantly higher than in lower MFP (about 8-fold for CDB4124 and 7-fold for CDB4453; p=0.000, p=0.000, respectively). In contrast, the pellet group shows a similar concentration of CDB4124 and CDB4453 in the upper and lower MFPs.Conclusions: This is an encouraging result because skin permeation of CDB4124 is similar to the level of estradiol, an efficacious transdermal agent, and indicating more extensive metabolism of CDB4124 when administered systemically. The high CDB4124 tissue level in the gel group indicate the possibility that drug smeared on the skin area other than the upper MFP, but the higher level of the metabolite CDB4453 supports the conclusion that a significant portion of the drug measured in the fat pad was in fact delivered to the tissue. Local transdermal delivery of CDB4124 seems plausible method for breast cancer prevention.Citation Format: Oukseub Lee, David Ivancic, Ali Shidfar, Ronald Wiehle, Seema A. Khan. In vitro and in vivo transdermal delivery of CDB4124, a progesterone receptor modulator: a potential method for breast cancer prevention . [abstract]. In: Proceedings of the 104th Annual Meeting of the American Association for Cancer Research; 2013 Apr 6-10; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2013;73(8 Suppl):Abstract nr 5670. doi:10.1158/1538-7445.AM2013-5670

01 Sep 2000·Reproduction

Effectiveness of zona pellucida protein ZPB as an immunocontraceptive antigen

Article

Author: Harris, J. D. ; Martinez, M. L.

Immunization of female mammals with native zona pellucida (ZP) proteins is known to cause infertility. Since each human ZP protein is now available as a purified recombinant protein, is it possible to compare the immunocontraceptive potential of each ZP protein. A breeding study was conducted in cynomolgus monkeys (Macaca fasicularis) after immunization with recombinant human ZP (rhZP) proteins (ZPA, ZPB, ZPC) separately and in combinations. This study demonstrated that immunization with recombinant human ZPB (rhZPB) protein caused cynomolgus monkeys to become infertile for 9-35 months. A second study was conducted in baboons (Papio cynocephalus), which yielded a similar result. The baboons immunized with rhZPB became infertile for 9 to > 20 months. During the time of maximum antibody titre, some animals experienced disruption of the menstrual cycle, but eventually all of the animals resumed normal menstrual cycles. Control animals and animals immunized with other rhZP proteins all became pregnant before any of the rhZPB-treated animals. This is the first study in which a recombinant ZP protein has consistently induced infertility in a primate without permanent disruption of the normal menstrual cycle.

News (Medical) associated with Repros Therapeutics, Inc.

28 Aug 2012

·www.biospace.com

Repros Therapeutics Inc. Release: FDA Provides Recommendations for Phase 2 Protocol for Low Dose Oral Proellex(R) in the Treatment of Endometriosis

THE WOODLANDS, Texas, Aug. 27, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced the FDA has provided guidance for a Phase 2 study of low dose oral Proellex® in the treatment of endometriosis. The following are the key elements of the guidance:

12 May 2008

·www.biospace.com

Repros Therapeutics Inc. Reports First Quarter 2008 Financial Results and Provides Clinical Development Program Overview

THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics (NasdaqGM:RPRX) today announces financial results for the first quarter ended March 31, 2008 and provides a clinical development program overview.

Financial Statement

10 Jan 2008

·www.biospace.com

Repros Therapeutics Inc. and Efficacy Capital Announce Standstill Agreement

THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqGM:RPRX) announced today that the Board of Directors has approved an amendment to its Shareholder Rights Plan that permits the Company's largest shareholder, Efficacy Capital, to purchase up to 33% of the Company's outstanding capital stock on the open market or in potential future purchases directly from Repros. Efficacy currently owns a percentage that is slightly below the current twenty percent (20%) threshold in the Rights Plan. In connection with this Amendment, the Company and Efficacy Capital have entered into a Standstill Agreement containing customary covenants and obligations restricting Efficacy from taking certain actions with respect to its shares. As part of the Standstill Agreement, the Company has agreed to appoint Mark Lappe, Managing Partner at Efficacy, as a director of the Company, should he elect to do so, and to provide Efficacy Capital with observer rights at the Company's board meetings.

100 Deals associated with Repros Therapeutics, Inc.

100 Translational Medicine associated with Repros Therapeutics, Inc.

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Enclomiphene citrate ( ER )	-	Phase 2
Telapristone Acetate ( PR )	Endometriosis More	Suspended
ERxin ( α-adrenergic receptor )	Erectile Dysfunction More	Discontinued
Bimexes ( α-adrenergic receptor )	Erectile Dysfunction More	Discontinued

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