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

NCT01266759 | Completed DMC

• 2 other identifiers: MU-261zFMH-245-C
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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

Conditions

Menorrhagia

Keywords

Menorrhagia; Vaginal ring; Norethisterone Acetate

Outcome Measures

Primary Outcomes (1)

• Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.

Secondary Outcomes (1)

• Haemoglobin and serum ferritin at the end of study (cycle 3)

Study Arms (2)

NuvaRing

EXPERIMENTAL

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

Norethisterone Acetate

ACTIVE COMPARATOR

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

Interventions

NuvaRing DRUG

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.

NuvaRing

Norethisterone Acetate tablets - 5mg DRUG

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

Norethisterone Acetate

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception

You may not qualify if:

• Menorrhagia of endocrine or systemic origin
• other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related 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.

  PMID: 18635169 BACKGROUND

• 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. doi: 10.1093/humrep/deh604. Epub 2004 Nov 11.

  PMID: 15539438 BACKGROUND

MeSH Terms

Conditions

Menorrhagia

Interventions

NuvaRing; Norethindrone Acetate

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Norethindrone; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hatem Abu Hashim, MD MRCOG

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

• Waleed El-Sherbini, MD

  Mansoura University Hospital

  STUDY DIRECTOR

• Mohamed Bazeed, MD

  Mansoura University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 24, 2010
• Study Start: July 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 24, 2010

Record last verified: 2010-12

Locations

EG (1)