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

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01266759
First received: December 22, 2010
Last updated: December 23, 2010
Last verified: December 2010

December 22, 2010
December 23, 2010
July 2008
September 2010   (final data collection date for primary outcome measure)
Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart. [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01266759 on ClinicalTrials.gov Archive Site
Haemoglobin and serum ferritin at the end of study (cycle 3) [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia
Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Menorrhagia
  • 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
  • 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.
    Intervention: Drug: NuvaRing
  • 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
    Intervention: Drug: Norethisterone Acetate tablets - 5mg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Female
20 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01266759
MU-261z, FMH-245-C
Yes
Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN, Mansoura Faculty of Medicine, Mansoura University.
Mansoura University
Not Provided
Principal Investigator: Hatem Abu Hashim, MD MRCOG Mansoura University Hospitals
Study Director: Waleed El-Sherbini, MD Mansoura University Hospitals
Study Chair: Mohamed Bazeed, MD Mansoura University Hospitals
Mansoura University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP