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

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT01266759
Collaborator
(none)
95
1
2
26
3.7

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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: 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.

Active Comparator: Norethisterone Acetate

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

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

Outcome Measures

Primary Outcome Measures

  1. Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart. []

Secondary Outcome Measures

  1. Haemoglobin and serum ferritin at the end of study (cycle 3) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception
Exclusion Criteria:
  • Menorrhagia of endocrine or systemic origin

  • other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University Hospitals,OB/GYN department Mansoura Dakahlia Governorate Egypt

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Principal Investigator: Hatem Abu Hashim, MD MRCOG, Mansoura University Hospital
  • Study Director: Waleed El-Sherbini, MD, Mansoura University Hospital
  • Study Chair: Mohamed Bazeed, MD, Mansoura University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01266759
Other Study ID Numbers:
  • MU-261z
  • FMH-245-C
First Posted:
Dec 24, 2010
Last Update Posted:
Dec 24, 2010
Last Verified:
Dec 1, 2010

Study Results

No Results Posted as of Dec 24, 2010