Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University
ClinicalTrials.gov Identifier:
NCT00563576
First received: November 21, 2007
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

Many women choose Depo-Provera for birth control because it is easy to use and very effective. However, a significant number of Depo-Provera users experience irregular bleeding during the first 90 days. Many users discontinue after their first injection due to irregular bleeding. This study will evaluate the effect of using an estrogen vaginal ring during the first 90 days of Depo-Provera use to see if it is acceptable to women and whether it decreases irregular bleeding during the first 90 days of use and increases continuation to a second injection.


Condition Intervention
Metrorrhagia
Drug: Femring®
Drug: DepoProvera ®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Mean Number of Bleeding or Spotting Days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Bleeding and spotting were defined using World Health Organization criteria and measured through daily diaries given to participants and collected at the 3 and 6 month followup. In addition, a study staff member called participants weekly to collect the daily bleeding and spotting calendar for that week to optimize the accuracy of this information.


Secondary Outcome Measures:
  • Percentage of Users Who Were Satisfied With Femring [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Acceptability was measured using questionnaires that assessed satisfaction of Femring and usage of the ring. This outcome was only measured among the intervention group of women who actually were randomized to use of Femring. Acceptability of the vaginal ring was high among those in the intervention group.

  • Number of Subjects Who Receive a 2nd Injection of Depo-Provera [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Percentage of Subjects Who Receive a 3rd Injection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: September 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Depo-Provera/Femring
Subjects will receive an estrogen vaginal ring (100 mcg) during the first 90 days of Depo-Provera use.
Drug: Femring®

Estrogen vaginal ring (100 mcg) placed for the first 90 days of Depo-Provera use.

Femring® (estradiol acetate vaginal ring) is a flexible off-white ring designed for vaginal insertion with measurements that include an outer diameter of 56 mm, cross-sectional diameter of 7.6 mm, and core diameter of 2 mm. Femring® 0.1 mg/day has a central core containing 24.8 mg of estradiol acetate which releases at a rate equivalent to 0.1 mg of estradiol per day for 3 months.

Other Name: Estradiol Acetate Vaginal Ring
Drug: DepoProvera ®
Medroxyprogesterone intramuscular injection comes as a suspension (liquid) to be injected into the buttocks or upper arm. It is usually given once every 3 months (13 weeks), and the recommended dose is 150 mg.
Other Name: Depot Medroxyprogesterone Acetate (DMPA)
Depo-Provera Injection Alone
Subjects will receive Depo-Provera intramuscular injection.
Drug: DepoProvera ®
Medroxyprogesterone intramuscular injection comes as a suspension (liquid) to be injected into the buttocks or upper arm. It is usually given once every 3 months (13 weeks), and the recommended dose is 150 mg.
Other Name: Depot Medroxyprogesterone Acetate (DMPA)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women age 18 or older who are initiating Depo-Provera for contraception
  • English or Spanish-speaking
  • Have a negative urine pregnancy test

Exclusion Criteria:

  • Contraindications to either Depo-Provera or Femring (estrogen vaginal ring)
  • Have used Depo-Provera or Mirena in the prior 6 months
  • Have had an induced abortion, spontaneous abortion, or birth in prior 8 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563576

Locations
United States, New York
Title X Family Planning Clinic
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Angela R Dempsey, MD, MPH Medical University of South Carolina
Principal Investigator: Carolyn Westhoff, MD, MSc Columbia University
  More Information

Publications:

Responsible Party: Carolyn L. Westhoff, Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT00563576     History of Changes
Other Study ID Numbers: AAAC6363, Depo with Femring
Study First Received: November 21, 2007
Results First Received: October 11, 2010
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Depo-Provera
Medroxyprogesterone Acetate
Metrorrhagia
Irregular Bleeding

Additional relevant MeSH terms:
Metrorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Medroxyprogesterone
Medroxyprogesterone Acetate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 22, 2014