Trial Outcomes & Findings for Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone (NCT NCT05726903)
NCT ID: NCT05726903
Last Updated: 2026-02-12
Results Overview
Patient satisfaction with DMPA as assessed by thematic analysis of audio-recorded focus groups of each individual participant. Satisfaction will be measured through thematic analysis as the transcripts for the focus groups are coded, identifying phrases and words relating to satisfaction or dissatisfaction with their injection experience. Focus groups will be led by a member of the trans-masculine young adult community who will be trained on focus group procedures. Guides will be developed from a collaboration between experts in gender-affirming care.
COMPLETED
PHASE4
35 participants
within 6 months of first DMPA administration
2026-02-12
Participant Flow
Participant milestones
| Measure |
Depo SC Home
Participants will be given instructions on home administration of DMPA SC and be provided with all necessary supplies.
Depo-subQ Provera Injectable Product: SC Injection at Home
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data for 1 person
Baseline characteristics by cohort
| Measure |
Depo SC Home
n=35 Participants
Participants will be given instructions on home administration of DMPA SC and be provided with all necessary supplies.
Depo-subQ Provera Injectable Product: SC Injection at Home
|
|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=34 Participants • Missing data for 1 person
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=34 Participants • Missing data for 1 person
|
|
Age, Categorical
>=65 years
|
0 Participants
n=34 Participants • Missing data for 1 person
|
|
Age, Continuous
|
17.5 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: within 6 months of first DMPA administrationPatient satisfaction with DMPA as assessed by thematic analysis of audio-recorded focus groups of each individual participant. Satisfaction will be measured through thematic analysis as the transcripts for the focus groups are coded, identifying phrases and words relating to satisfaction or dissatisfaction with their injection experience. Focus groups will be led by a member of the trans-masculine young adult community who will be trained on focus group procedures. Guides will be developed from a collaboration between experts in gender-affirming care.
Outcome measures
| Measure |
DMPA SC Users
n=17 Participants
Participants will be given instructions on home administration of DMPA SC and be provided with all necessary supplies.
Depo-subQ Provera Injectable Product: SC Injection at Home
|
|---|---|
|
Number of Participants Satisfied With Self-Administered DMPA at Initiation
|
17 Participants
|
PRIMARY outcome
Timeframe: within 2 months of first DMPA administrationPatient satisfaction with DMPA as assessed by thematic analysis of audio-recorded focus groups of each individual participant. Satisfaction will be measured through thematic analysis as the transcripts for the focus groups are coded, identifying phrases and words relating to satisfaction or dissatisfaction with their injection experience. Focus groups will be led by a member of the trans-masculine young adult community who will be trained on focus group procedures. Guides will be developed from a collaboration between experts in gender-affirming care. Patients who elect for DMPA administration in an office setting will not undergo individual interviews.
Outcome measures
| Measure |
DMPA SC Users
n=4 Participants
Participants will be given instructions on home administration of DMPA SC and be provided with all necessary supplies.
Depo-subQ Provera Injectable Product: SC Injection at Home
|
|---|---|
|
Number of Participants Satisfied With DMPA in an Office Setting
|
4 Participants
|
Adverse Events
Depo SC Home
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Assistant Professor, Division of Family Planning
University of Colorado School of Medicine, Department of OBGYN
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place