Trial Outcomes & Findings for Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation (NCT NCT00563576)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

71 participants

Primary outcome timeframe

3 months

Results posted on

2021-12-15

Participant Flow

Participants were recruited from a Title X Family Planning Clinic in New York City.

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.

Participant milestones

Participant milestones
Measure	Femring Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.	Depot Medroxyprogesterone Acetate (DMPA) Alone Subjects will receive Depo-Provera intramuscular injection.
Overall Study STARTED	35	36
Overall Study COMPLETED	21	22
Overall Study NOT COMPLETED	14	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Femring n=35 Participants Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.	Depot Medroxyprogesterone Acetate (DMPA) Alone n=36 Participants Subjects will receive Depo-Provera intramuscular injection.	Total n=71 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	36 participants n=7 Participants	71 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Femring n=35 Participants Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.	Depot Medroxyprogesterone Acetate (DMPA) Alone n=36 Participants Subjects will receive Depo-Provera intramuscular injection.
Mean Number of Bleeding or Spotting Days	16 days Standard Deviation 0.19	28 days Standard Deviation 0.19

SECONDARY outcome

Timeframe: 3 months

Population: Acceptability was reported among the 26 participants in the Femring group who were available for followup, i.e., per protocol.

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.

Outcome measures

Outcome measures
Measure	Femring n=26 Participants Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.	Depot Medroxyprogesterone Acetate (DMPA) Alone Subjects will receive Depo-Provera intramuscular injection.
Percentage of Users Who Were Satisfied With Femring	84 participants	—

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Femring n=35 Participants Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.	Depot Medroxyprogesterone Acetate (DMPA) Alone n=36 Participants Subjects will receive Depo-Provera intramuscular injection.
Number of Subjects Who Receive a 2nd Injection of Depo-Provera	20 participants	16 participants

SECONDARY outcome

Timeframe: 6 months

Population: Only the women who completed the study up to the secondary endpoint were included in this analysis.

Outcome measures

Outcome measures
Measure	Femring n=17 Participants Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.	Depot Medroxyprogesterone Acetate (DMPA) Alone n=16 Participants Subjects will receive Depo-Provera intramuscular injection.
Percentage of Subjects Who Receive a 3rd Injection	13 Participants	10 Participants

Adverse Events

Femring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Depot Medroxyprogesterone Acetate (DMPA) Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carolyn Westhoff

Columiba University

Phone: 212-305-4805

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place