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

Primary Purpose

Menorrhagia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
NuvaRing
Norethisterone Acetate tablets - 5mg
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring Menorrhagia, Vaginal ring, Norethisterone Acetate

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura University Hospitals,OB/GYN department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NuvaRing

Norethisterone Acetate

Arm Description

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 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

Outcomes

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)

Full Information

First Posted
December 22, 2010
Last Updated
December 23, 2010
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01266759
Brief Title
Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia
Official Title
Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
Menorrhagia, Vaginal ring, Norethisterone Acetate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NuvaRing
Arm Type
Experimental
Arm Description
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.
Arm Title
Norethisterone Acetate
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
NuvaRing
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Norethisterone Acetate tablets - 5mg
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.
Secondary Outcome Measure Information:
Title
Haemoglobin and serum ferritin at the end of study (cycle 3)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Abu Hashim, MD MRCOG
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waleed El-Sherbini, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Bazeed, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Hospitals,OB/GYN department
City
Mansoura
State/Province
Dakahlia Governorate
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
18635169
Citation
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.
Results Reference
background
PubMed Identifier
15539438
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. doi: 10.1093/humrep/deh604. Epub 2004 Nov 11.
Results Reference
background

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

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