Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Segesterone and Ethinyl Estradiol · 2 trials · 2 indications
AUC for 24 hours
AUC for 24 hours for segesterone acetate and ethinyl estradiol
Cmax for segesterone acetate and ethinyl estradiol
| Arm | Type | Description |
|---|---|---|
| Annovera (alone) | ACTIVE_COMPARATOR | Annovera without tampon use |
| Annovera with tampon use | ACTIVE_COMPARATOR | Annovera with tampon use |
| Annovera with itraconazole use | ACTIVE_COMPARATOR | Subjects will dose with 200 mg/day of itraconazole for five days before Annovera insertion and through Days 1 to 8 of Annovera use |
| Annovera with rifampin use | ACTIVE_COMPARATOR | Subjects will dose with 600 mg/day rifampin for 8 days, between Days 4 to 11 of Annovera use during their respective treatment cycles |
| Name | Type | Description |
|---|---|---|
| Segesterone Acetate and Ethinyl Estradiol | DRUG | Annovera taken alone |
| Tampon | OTHER | Annovera with tampon use |
| Rifampin | DRUG | CYP3A inducer |
| Itraconazole | DRUG | CYP3A inhibitor |
Inclusion Criteria All of the following criteria must be met for the participants to be eligible for the study: 1. Healthy women, sterile or at risk of becoming pregnant, inclusive of ages 18 to 35\* years at the enrollment visit. 2. Intact uterus and both ovaries. 3. Prior history of regular mens...
Segesterone and Ethinyl Estradiol is a contraceptive product for women. It is a small molecule combination therapy in the endocrine therapeutic area. The clinical trials for this asset enrolled healthy female volunteers aged 18 years and older and evaluated contraception-related outcomes.
Segesterone and Ethinyl Estradiol is developed by TherapeuticsMD, Inc., which trades under the ticker TXMD. The company is the sponsor of the clinical trials evaluating this contraceptive combination.
Segesterone and Ethinyl Estradiol is in Phase 1 clinical development. The program has one completed Phase 1 trial and no active trials. It is an investigational product and has not been approved by the FDA.
Segesterone and Ethinyl Estradiol has been studied in two completed Phase 1 trials. NCT04290390 was an Annovera drug-drug interaction study with 67 enrolled participants in Canada. NCT04272008 examined the effects of Annovera and tampon co-usage on the pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol, enrolling 21 participants in the United States and Canada.