NCT03737656

Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women

Open-label, Randomized, Clinical Trial With Three Groups for the Characterization of Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single site, open-label, randomized, single-dose, Phase 1 study in post-menopausal women.

Detailed description

The objective of the study is to characterize the pharmacokinetics of progesterone in post-menopausal women after the insertion of a vaginal ring containing 2.0 g of progesterone. Progesterone is slowly released from the ring within 90 days (sustained-release). Study participants will use the vaginal ring for a period of 91 days (13 weeks). Progesterone blood concentrations will be determined during the use of the vaginal ring and after removal of the vaginal ring after a period of use of 13 weeks. In subgroups of participants, progesterone blood concentrations will also be determined after removal of the ring for a period of 2 hours or 4 hours on Day 28 of use. A study participant has completed the study when the final evaluation takes place, which is 7-15 days after removal of the vaginal ring on Day 91. The safety of the progesterone vaginal ring will be assessed based on the adverse events reported.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Progesterone vaginal ring	Vaginal ring with 2.0 g progesterone (sustained-release over 90-days)

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-05-03
• Completion: 2019-05-09
• First posted: 2018-11-09
• Last updated: 2019-06-05

Locations

1 site across 1 country: Mexico