NCT01839643

Assessment of a Vaginal Ring With Meloxicam on Ovarian Cycle in Fertile Women

Phase 1 Study of Assessment of Local Absorption of a Non-steroidal Antiinflammatory Drug (NSAID), Inhibitor of Cyclooxygenase 2 (COX-2) Meloxicam, Through a Vaginal Ring and Its Effect on Ovarian Cycle in Fertile Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Laboratorios Andromaco S.A. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

In this study, the investigators propose to assess if a non-hormonal agent is absorbed by a local route (vaginal) and to observe the effect on follicular development.

Detailed description

Each volunteer will participate for 3 menstrual cycles, beginning with one menstrual control cycle without treatment, following by one menstrual cycle with meloxicam ring administration, and finishing with another control menstrual cycle. Meloxicam will be administered in the second menstrual cycle via a vaginal ring in two doses of 2.4 g or 3.0 g/ring. The safety of the vaginal ring and the absorption of meloxicam will be assessed. Also the effect on follicular development and if it maintains ovarian cyclicity, as shown in a recent study with oral administration, will be assessed.

Conditions

• Contraception
• Bleeding Pattern

Interventions

Type	Name	Description
DRUG	Meloxicam 2.4 g	2.4 g in Vaginal Ring
DRUG	Meloxicam 3.0 g	3.0 g in Vaginal Ring

Timeline

• Start date: 2013-01-15
• Primary completion: 2013-05-07
• Completion: 2013-06-06
• First posted: 2013-04-25
• Last updated: 2019-04-30

Locations

1 site across 1 country: Chile