N/A
N=71
Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation
Metrorrhagia
Bottom Line
View on ClinicalTrials.gov: NCT00563576 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Mean Number of Bleeding or Spotting Days — 16; 28 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Femring® (Drug); DepoProvera ® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Bleeding or Spotting Days |
16; 28 | — |
| SECONDARY Percentage of Users Who Were Satisfied With Femring |
84 | — |
| SECONDARY Number of Subjects Who Receive a 2nd Injection of Depo-Provera |
20; 16 | — |
| SECONDARY Percentage of Subjects Who Receive a 3rd Injection |
13; 10 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00563576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.