6 completed, 1 terminated. 4 Phase 3, 2 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Completed 3, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 2 | 1 | Completed 1 |
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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 |
|---|---|---|---|---|---|---|
| The Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol Segesterone Acetate and Ethinyl Estradiol, Tampon - Contraception | Phase 1 | Completed | TherapeuticsMD | 21 | 2020-03-06 | 2021-10-29 |
| Annovera™ Drug-Drug Interaction Study Segesterone Acetate and Ethinyl Estradiol, Rifampin, Itraconazole - Women, Contraception | Phase 1 | Completed | TherapeuticsMD | 67 | 2020-02-12 | 2021-01-29 |
| Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women oral estradiol 1.0 mg, oral progesterone 100 mg - Menopause | Phase 3 | Completed | Intira Sriprasert | 20 | 2015-12-01 | 2020-03-19 |
| Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women Estradiol, Placebo - Vulvovaginal Atrophy, Menopause | Phase 3 | Completed | TherapeuticsMD | 764 | 2014-09-01 | 2017-05-25 |
| A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding for Secondary Amenorrhea Progesterone, Placebo - Secondary Amenorrhea | Phase 3 | Terminated | TherapeuticsMD | 6 | 2014-01-20 | 2018-05-08 |
| A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms Estradiol, Progesterone, Placebo - Menopause | Phase 3 | Completed | TherapeuticsMD | 1845 | 2013-08-05 | 2019-05-06 |
| TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy Estradiol, placebo - Menopause, Vulvovaginal Atrophy | Phase 2 | Completed | TherapeuticsMD | 50 | 2013-07-01 | 2015-12-14 |
Dyspareunia (2) · Hot Flashes (1)
Estradiol (4) · Progesterone (3) · segesterone acetate and ethinyl estradiol vaginal system (2) · Itraconazole (1) · Rifampin (1)
United States (6) · Canada (3)
Sebastian Mirkin, MD (3) · David F Archer, MD (1) · Shelli Graham, PhD (1)
PMID 25835751, PMID 28355090, PMID 29889748, PMID 30238814, PMID 30586005, PMID 30601452, PMID 31364889, PMID 31688572, PMID 31913228, PMID 32740481, PMID 32932401, PMID 33110039, PMID 34054104, PMID 35213517, PMID 37619252, PMID 41291952