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

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ClinicalTrials.gov Identifier: NCT01266759
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : December 24, 2010
Sponsor:
Information provided by:

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
Menorrhagia Drug: NuvaRing Drug: Norethisterone Acetate tablets - 5mg

Study Design

Study Type : Interventional  (Clinical Trial)
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 : July 2008
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266759


Locations
Egypt
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 Hospitals
Study Director: Waleed El-Sherbini, MD Mansoura University Hospitals
Study Chair: Mohamed Bazeed, MD Mansoura University Hospitals
More Information

Publications:
Responsible Party: Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN, Mansoura Faculty of Medicine, Mansoura University.
ClinicalTrials.gov Identifier: NCT01266759     History of Changes
Other Study ID Numbers: MU-261z
FMH-245-C
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: December 24, 2010
Last Verified: December 2010

Keywords provided by Mansoura University:
Menorrhagia
Vaginal ring
Norethisterone Acetate

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Contraceptive Agents
Norethindrone
Norethindrone acetate
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female