A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects

An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Commercial Femulen Tablets Versus Reformulated Femulen Tablets In Healthy Female Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01359163

Enrollment

Registered

2011-05-24

Start date

2011-06-30

Completion date

2011-07-31

Last updated

2012-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Therapeutic Equivalency

Keywords

bioequivalence study, marketed vs reformulation tablets, Femulen

Brief summary

A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects.

Interventions

DRUGetynodiol diacetate

tablet, 0.5 mg, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 55 Years

Healthy volunteers

Yes

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 examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.

Exclusion criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * Any condition possibly affecting drug absorption (eg, gastrectomy).

Design outcomes

Primary

Measure	Time frame
Area under the curve to last time point observed (AUCt)	0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Highest concentration (Cmax)	0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48

Secondary

Measure	Time frame
Area under the curve to infinity (AUCinf)	0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Area under the curve percent to infinity (AUC%inf)	0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Half-life (T1/2)	0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Time at maximum concentration (Tmax)	0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026