A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Progesterone vaginal ring,

• Registration Number: NCT02092571
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

A study to assess the pharmacokinetics of 2 progesterone vaginal rings in postmenopausal women

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-28
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-20
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-06
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Progesterone vaginal ring,	1 ring intravaginal for 7 days, produced from the new process
Treatment B	Progesterone vaginal ring,	1 ring intravaginal for 7 days, produced from the legacy process

Primary Outcome Measures

Name	Time	Method
baseline-adjusted AUCt	16 weeks
baseline-adjusted AUC∞	16 weeks
baseline-adjusted Cmax	16 weeks

Secondary Outcome Measures

Name	Time	Method
baseline-unadjusted λz	16 weeks
baseline-adjusted t½	16 weeks
baseline-unadjusted t½	16 weeks
baseline-adjusted tmax	16 weeks
baseline-unadjusted AUCt	16 weeks
baseline-adjusted λz	16 weeks
baseline-unadjusted AUC∞	16 weeks
baseline-unadjusted Cmax	16 weeks
baseline-unadjusted tmax	16 weeks

Trial Locations

Locations (1)

Teva Investigational Site 12355; 🇺🇸 Miami, Florida, United States