ST 1435: Clinical Trials

8 completed. 4 Phase 1, 2 Phase 2, 2 Phase 3.

By phase and status

Phase	Trials	Status
Phase 1	4	Completed 4
Phase 2	2	Completed 2
Phase 3	2	Completed 2

Follow ST 1435: new trials by email Literature Review of ST 1435 trials Research Report on ST 1435

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception Nestorone + Testosterone Combination Gel - Healthy, Men	Phase 2	Completed	Premier Research	420	2018-10-25	2025-02-18
Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males Nestorone + Testosterone Combination Gel - Healthy Men, Male Contraception	Phase 1	Completed	Kimberly Myer	26	2017-01-01	2026-02-09
Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men Nestorone® /testosterone gel, Testosterone only gel - Healthy	Phase 1	Completed	Kimberly Myer	44	2015-04-01	2025-02-13
An Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication Miconazole Nitrate on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring in Normal Ovulating Women NES/EE CVR - Antifungal Drug Adverse Reaction	Phase 1	Completed	Population Council	45	2014-03-01	2017-08-15
Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men Testosterone, Nestorone® - Contraception	Phase 1	Completed	Premier Research	99	2009-05-01	2018-05-24
Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR) - Contraception	Phase 3	Completed	Premier Research	1200	2006-12-01	2026-01-23
Safety and Efficacy of a Contraceptive Vaginal Ring Delivering Nestorone® and Ethinyl Estradiol NES/EE CVR - Contraception	Phase 3	Completed	Population Council	1135	2005-12-01	2017-10-06
Effects of Hormonal Contraceptives on Liver Proteins and Coagulation Factors: A Comparison of a Contraceptive Vaginal Ring and an Oral Contraceptive Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive - Contraception	Phase 2	Completed	Population Council	50	2003-03-01	2017-08-14

Conditions studied

Multiple Endocrine Neoplasia Type 1 (1)

Sponsors

Population Council (3)  ·  Premier Research (3)  ·  Kimberly Myer (2)

Countries

United States (7)  ·  Chile (2)  ·  Sweden (2)  ·  Australia (1)  ·  Brazil (1)  ·  Dominican Republic (1)  ·  Finland (1)  ·  Hungary (1)  ·  Italy (1)  ·  Kenya (1)  ·  Netherlands (1)  ·  United Kingdom (1)  ·  Zimbabwe (1)

Top investigators

Christina Wang, MD (3)  ·  Bradley Anawalt, MD (1)  ·  Dennis Morrison, MD (1)  ·  Diana Blithe, PhD (1)  ·  Diana L. Blithe, PH.D. (1)  ·  Regine Sitruk-Ware, MD (1)  ·  Ruth Merkatz, Ph.D. (1)  ·  William Bremner, MD (1)  ·  William Bremner, MD, PhD (1)

Results publications

PMID 26267119, PMID 31231065, PMID 31398307, PMID 38295968, PMID 24993487, PMID 29097225, PMID 29269252, PMID 30556332, PMID 36347310, PMID 37253139