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Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00563576
Recruitment Status : Completed
First Posted : November 26, 2007
Results First Posted : July 21, 2011
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Metrorrhagia
Interventions Drug: Femring®
Drug: DepoProvera ®
Enrollment 71
Recruitment Details Participants were recruited from a Title X Family Planning Clinic in New York City.
Pre-assignment Details Women seeking DMPA eligible to participate it 18 years old, English or Spanish speaking, had not used DMPA or Levonorgestrel intrauterine system in the preceeding 120 days. Women reporting oligomenorrheas (defined as fewer that 4 periods in the last 6 months), amenorrhea, or contraindications to either DMPA or estrogen were excluded.
Arm/Group Title Femring Depot Medroxyprogesterone Acetate (DMPA) Alone
Hide Arm/Group Description Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use. Subjects will receive Depo-Provera intramuscular injection.
Period Title: Overall Study
Started 35 36
Completed 21 22
Not Completed 14 14
Arm/Group Title Femring Depot Medroxyprogesterone Acetate (DMPA) Alone Total
Hide Arm/Group Description Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use. Subjects will receive Depo-Provera intramuscular injection. Total of all reporting groups
Overall Number of Baseline Participants 35 36 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 71 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
 100.0%
36
 100.0%
71
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 71 participants
Female
35
 100.0%
36
 100.0%
71
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 36 participants 71 participants
35 36 71
1.Primary Outcome
Title Mean Number of Bleeding or Spotting Days
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femring Depot Medroxyprogesterone Acetate (DMPA) Alone
Hide Arm/Group Description:
Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
Subjects will receive Depo-Provera intramuscular injection.
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: days
16  (0.19) 28  (0.19)
2.Secondary Outcome
Title Percentage of Users Who Were Satisfied With Femring
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Acceptability was reported among the 26 participants in the Femring group who were available for followup, i.e., per protocol.
Arm/Group Title Femring Depot Medroxyprogesterone Acetate (DMPA) Alone
Hide Arm/Group Description:
Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
Subjects will receive Depo-Provera intramuscular injection.
Overall Number of Participants Analyzed 26 0
Measure Type: Number
Unit of Measure: participants
84
3.Secondary Outcome
Title Number of Subjects Who Receive a 2nd Injection of Depo-Provera
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femring Depot Medroxyprogesterone Acetate (DMPA) Alone
Hide Arm/Group Description:
Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
Subjects will receive Depo-Provera intramuscular injection.
Overall Number of Participants Analyzed 35 36
Measure Type: Number
Unit of Measure: participants
20 16
4.Secondary Outcome
Title Percentage of Subjects Who Receive a 3rd Injection
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femring Depot Medroxyprogesterone Acetate (DMPA) Alone
Hide Arm/Group Description:
Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
Subjects will receive Depo-Provera intramuscular injection.
Overall Number of Participants Analyzed 17 16
Measure Type: Count of Participants
Unit of Measure: Participants
13
  76.5%
10
  62.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Femring Depot Medroxyprogesterone Acetate (DMPA) Alone
Hide Arm/Group Description Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use. Subjects will receive Depo-Provera intramuscular injection.
All-Cause Mortality
Femring Depot Medroxyprogesterone Acetate (DMPA) Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Femring Depot Medroxyprogesterone Acetate (DMPA) Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Femring Depot Medroxyprogesterone Acetate (DMPA) Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/36 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carolyn Westhoff
Organization: Columiba University
Phone: 212-305-4805
EMail: clw3@columbia.edu
Publications:
Layout table for additonal information
Responsible Party: Carolyn L. Westhoff, Columbia University
ClinicalTrials.gov Identifier: NCT00563576     History of Changes
Other Study ID Numbers: AAAC6363
First Submitted: November 21, 2007
First Posted: November 26, 2007
Results First Submitted: October 11, 2010
Results First Posted: July 21, 2011
Last Update Posted: April 17, 2019