Status:
COMPLETED
Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea
Lead Sponsor:
Laboratorios Andromaco S.A.
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators propose that the sustained administration of a vaginal ring would have a better response with respect to pain and a better safety profile than the oral administration of a non-steroi...
Eligibility Criteria
Inclusion
- Regular menstrual cycles on previous 3 months (24-35 days),
- Primary dysmenorrhea on 3 previous months,
- With tubal ligation or users of condom for contraception,
- Hemoglobin of at least 11 g/dl,
- Safety blood analysis in normal levels
Exclusion
- Secondary dysmenorrhea,
- Users of hormonal contraceptives (2 months prior to the study) or intrauterine devices (IUDs) (1 month prior the study).
- Allergy to any anti-inflammatory drug including meloxicam or diclofenac.
- Allergy to silicon.
- Pregnant or in lactation.
- Women with untreated or decompensated endocrine disorders
Key Trial Info
Start Date :
June 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2016
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT02255045
Start Date
June 27 2014
End Date
March 16 2016
Last Update
May 3 2019
Active Locations (1)
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1
Instituto Chileno de Medicina Reproductiva (ICMER)
Santiago, Chile, 8320165