Clinical Trial: Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation

Brief Summary: 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.

Detailed Summary:

Many women choose depot medroxyprogesterone acetate (DMPA) for contraception because it is long-acting, highly effective, and requires minimal user involvement. One of the most common side effects of DMPA use during the first 90 day cycle is irregular bleeding. There are few studies that report mean number of bleeding days among DMPA users. A large World Health Organization (WHO) trial including ten international centers and menstrual data on 748 women using DMPA including 372 woman-years of follow-up reported 23.6 mean days of spotting and bleeding during the first cycle with a standard deviation of 18.9 days (WHO). Another study sponsored by WHO (n=575) reported that 25% of subjects had bleeding/spotting episodes during the first cycle of DMPA that exceeded 13 days. The number of bleeding/spotting days and number of bleeding/spotting episodes decreased over successive reference periods (Said 1987).

Discontinuation rates are high after the first injection and related to irregular bleeding. Rates of discontinuation after the first injection range from 15-60% but were around 30% in most studies (Harel, Paul, Polaneczy, Lim, Hubacher, Sangi, Rickert). Several studies noted that the largest percentage of discontinuation during the first year of DMPA use occurs after the first injection (Rickert, Hubacher, Lim). Irregular bleeding is uniformly cited as one of the most common reasons for discontinuation, accounting for 17-60% of all reasons given (Harel, Paul, Polaneczy, Lim, Sangi). An intervention to prevent or minimize irregular bleeding during the first 90 days of DMPA use could potentially minimize or prevent this bothersome side effect and thus improve continuation.

Few studies have examined the effect of prophylactic or therapeutic estrogen supplementation on irregular bleeding in DMPA users. A randomized trial (n=132) o
Sponsor: Columbia University

Current Primary Outcome: Mean Number of Bleeding or Spotting Days [ Time Frame: 3 months ]

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.


Original Primary Outcome: Acceptability [ Time Frame: 3 months ]

Current Secondary Outcome:

  • Percentage of Users Who Were Satisfied With Femring [ Time Frame: 3 months ]
    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 ]
  • Percentage of Subjects Who Receive a 3rd Injection [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Mean Number of Bleeding/Spotting Days [ Time Frame: 6 months ]
  • Percentage of Subjects Who Receive a 2nd Injection of Depo-Provera [ Time Frame: 3 months ]
  • Percentage of Subjects Who Receive a 3rd Injection [ Time Frame: 6 months ]


Information By: Columbia University

Dates:
Date Received: November 21, 2007
Date Started: September 2007
Date Completion:
Last Updated: December 11, 2012
Last Verified: December 2012