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 combination of two hormones used for contraception in women. It is being developed by TherapeuticsMD, Inc. as a small molecule product. The drug is currently in Phase 1 clinical development, meaning it is investigational and not yet approved for use.
Segesterone and Ethinyl Estradiol is being developed by TherapeuticsMD, Inc., a company traded under the ticker symbol TXMD. The product is intended for contraception in women and is currently in Phase 1 clinical trials. TherapeuticsMD is conducting studies to evaluate the drug's effects and interactions.
Segesterone and Ethinyl Estradiol is in Phase 1 clinical development. It is an investigational product being studied for contraception in women. Two Phase 1 trials have been completed, with a total of 67 participants enrolled. The drug has not yet been approved by regulatory authorities.
Segesterone and Ethinyl Estradiol has completed two Phase 1 clinical trials. NCT04272008 studied the effects of co-usage with tampons on the drug's pharmacokinetics in 21 healthy female volunteers. NCT04290390 was a drug-drug interaction study involving 67 healthy female volunteers. Both trials were conducted in the United States and Canada.
Segesterone and Ethinyl Estradiol is the active hormonal combination in the product known as Annovera. The clinical trials NCT04272008 and NCT04290390 both reference Annovera in their titles, indicating that the drug is being studied as part of this contraceptive product. Annovera is a vaginal ring system.