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Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia

NCT01266759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2010-12-24

No results posted yet for this study

Summary

To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age

Conditions

  • Menorrhagia

Interventions

DRUG

NuvaRing

For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.

DRUG

Norethisterone Acetate tablets - 5mg

Norethisterone Acetate tablets 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Hatem Abu Hashim, MD MRCOG · Mansoura University Hospital

  • Waleed El-Sherbini, MD · Mansoura University Hospital

  • Mohamed Bazeed, MD · Mansoura University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01266759 on ClinicalTrials.gov