Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia - Full Text View

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia

Resource links provided by NLM:

MedlinePlus related topics: Menstruation

Drug Information available for: Norethindrone acetate Norethindrone

U.S. FDA Resources

Further study details as provided by Mansoura University:

Primary Outcome Measures:

Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart. [ Designated as safety issue: No ]

Secondary Outcome Measures:

Haemoglobin and serum ferritin at the end of study (cycle 3) [ Designated as safety issue: No ]

Enrollment:	95
Study Start Date:	July 2008
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	20 Years to 35 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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. 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.

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
Study First Received:	December 22, 2010
Last Updated:	December 23, 2010
Health Authority:	Egypt: Institutional Review Board

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
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 21, 2013