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

Menorrhagia Clinical Trial

Official title:

Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266759
• Other study ID #: MU-261z
• Secondary ID: FMH-245-C
• Status: Completed
• Phase: N/A
• First received: December 22, 2010
• Last updated: December 23, 2010
• Start date: July 2008
• Est. completion date: September 2010

Study information

• Verified date: December 2010
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals,OB/GYN department	Mansoura	Dakahlia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.			No
Secondary	Haemoglobin and serum ferritin at the end of study (cycle 3)			No