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

Laboratorios Andromaco

Status and phase

Completed

Phase 1

Conditions

Contraception

Bleeding Pattern

Treatments

Drug: Meloxicam 2.4 g

Drug: Meloxicam 3.0 g

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01839643

AVM-01001

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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