Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia
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 |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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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
- Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart. []
Secondary Outcome Measures
- Haemoglobin and serum ferritin at the end of study (cycle 3) []
Eligibility Criteria
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
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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 | |
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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
- Matteson KA, Boardman LA, Munro MG, Clark MA. Abnormal uterine bleeding: a review of patient-based outcome measures. Fertil Steril. 2009 Jul;92(1):205-16. doi: 10.1016/j.fertnstert.2008.04.023. Epub 2008 Jul 16. Review.
- Oddsson K, Leifels-Fischer B, Wiel-Masson D, de Melo NR, Benedetto C, Verhoeven CH, Dieben TO. Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial. Hum Reprod. 2005 Feb;20(2):557-62. Epub 2004 Nov 11.
- MU-261z
- FMH-245-C