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

Contraception Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bleeding Pattern
• Contraception

• NCT number: NCT01839643
• Study type: Interventional
• Source: Laboratorios Andromaco S.A.
• Status: Completed
• Phase: Phase 1
• Start date: January 15, 2013
• Completion date: June 6, 2013