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

Phase 1

Completed

• Conditions: Contraception; Bleeding Pattern
• Interventions: Drug: Meloxicam 2.4 g; Drug: Meloxicam 3.0 g

• Registration Number: NCT01839643
• Lead Sponsor: Laboratorios Andromaco S.A.

Brief 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.

Study Timeline

• Study Start: 2013-01-15
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Primary Completion: 2013-05-07
• Study Completion: 2013-06-06
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.4 g Meloxicam Vaginal Ring	Meloxicam 2.4 g	Continuous wearing during one menstrual cycle (6 participants)
3.0 g Meloxicam Vaginal Ring	Meloxicam 3.0 g	Continuous wearing during one menstrual cycle (6 participants)

Primary Outcome Measures

Name	Time	Method
Number of participants with follicular rupture delay	Participants will be followed for the duration of one menstrual cycle, an expected average of 28 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto Chileno de Medicina Reproductiva (ICMER); 🇨🇱 Santiago, Chile