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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Contraception, Bleeding Pattern

Intervention / Treatment
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* Drug: Meloxicam 2.4 g
* Drug: Meloxicam 3.0 g


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2.4 g Meloxicam Vaginal Ring<br>Continuous wearing during one menstrual cycle (6 participants) | Drug: Meloxicam 2.4 g<br>* 2.4 g in Vaginal Ring<br>|
| Experimental: 3.0 g Meloxicam Vaginal Ring<br>Continuous wearing during one menstrual cycle (6 participants) | Drug: Meloxicam 3.0 g<br>* 3.0 g in Vaginal Ring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with follicular rupture delay | Evaluate effective dose of maximum local safety that causes a greater proportion of follicular rupture delays when it is administered continuously, starting on the day 5 +/- 1 of the cycle until next menses. | Participants will be followed for the duration of one menstrual cycle, an expected average of 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic of meloxicam via vaginal route: AUC | The AUC of meloxicam serum levels | An expected average of 28 days | 
| Bleeding patterns with meloxicam vaginal ring | Women will complete a menstrual diary during their participation to evaluate the effects of treatment on the menstrual pattern. | one menstrual cycle | 
| Pharmacokinetic of meloxicam via vaginal route: Tmax | Tmax of meloxicam serum levels | An expected average of 28 days | 
| Pharmacokinetic of meloxicam via vaginal route: Cmax | Cmax of meloxicam serum levels | An expected average of 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetic