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

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.

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.

Inclusion Criteria:

• Previous (or history of) proven fertility
• Regular menstrual cycle
• Surgically sterile
• Without breastfeeding
• Haemoglobin at least 11g/dL
• Willing to participate in the study

Exclusion Criteria:

• Allergy to meloxicam or other NSAID
• Allergy to silicone polymer
• Vaginal discharge non diagnosticated
• History of shock toxic syndrome
• History of : gastrointestinal, bleeding, renal, liver, heart, brain,clot, endocrine or pulmonary disorders