Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
etynodiol diacetate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Femulen commercial tablets | ACTIVE_COMPARATOR | - |
| Femulen reformulated tablets | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| etynodiol diacetate | DRUG | tablet, 0.5 mg, single dose |
Inclusion Criteria: * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs). * Healthy female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical e...
Etynodiol diacetate is a small molecule being studied for therapeutic equivalency, specifically to determine bioequivalence between the commercial Femulen tablets and a reformulation of Femulen tablets in healthy female subjects. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
Etynodiol diacetate is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical trials to evaluate the bioequivalence of different formulations of the drug.
Etynodiol diacetate is in Phase 1 clinical development. The single completed trial, NCT01359163, was a Phase 1 study that has been completed. The drug is investigational and has not received FDA approval.
Etynodiol diacetate has one completed clinical trial, NCT01359163, titled 'A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects.' This Phase 1 study enrolled 20 healthy female volunteers in Singapore and was active-controlled.
Etynodiol diacetate is the active ingredient in Femulen tablets. The clinical trial NCT01359163 compares the commercial Femulen tablets with a reformulation of Femulen tablets to assess bioequivalence, indicating that etynodiol diacetate is the drug substance in these products.