Status:
COMPLETED
Assessment of a Vaginal Ring With Meloxicam on Ovarian Cycle in Fertile Women
Lead Sponsor:
Laboratorios Andromaco S.A.
Collaborating Sponsors:
Instituto Chileno de Medicina Reproductiva
Conditions:
Contraception
Bleeding Pattern
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01839643
Start Date
January 15 2013
End Date
June 6 2013
Last Update
April 30 2019
Active Locations (1)
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1
Instituto Chileno de Medicina Reproductiva (ICMER)
Santiago, Chile, 8320165