An interventional study of Medroxyprogesterone 17-Acetate and Medroxyprogesterone 17-Acetate in Contraception, sponsored by Carolyn L. Westhoff. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by Carolyn L. Westhoff · Not applicable, Interventional, and Prevention
Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for many women. However, difficulty in access may cause many women to discontinue use, often without the use of another effective method of contraception, thereby leaving them vulnerable to unintended pregnancy. This study will randomly assign women who present for contraceptive services to two groups: self or clinic administered SC DMPA. The participants will be followed for one year to compare continuation rates, acceptability, cost effectiveness, evidence of skin changes, and need for continued support between the two groups.
Unintended pregnancy remains a worldwide problem in both developed and developing countries. In 2001, 49% of pregnancies in the United States were unintended. Moreover, more than 6 million women annually are at high risk of becoming unintentionally pregnant because of a gap in contraceptive use, and disadvantaged women are more likely to have more difficulty than others with continuous method use. Multiple strategies have been explored and implemented to increase the effective usage of contraception, including promoting the use of longer acting reversible contraceptives.
Difficulty in access to depot medroxyprogesterone acetate (DMPA) remains a problem. With the advent of a subcutaneous formulation of DMPA, administration outside of the clinical setting is possible. The acceptability of self administered DMPA has also been reviewed, with favorable outcomes; however, the actual intervention has not been studied.
This study will recruit women presenting for abortion or contraceptive services at the Columbia University and New York Presbyterian affiliated Family Planning Clinic and Special Gynecology Services who desire DMPA for contraception. Women will be randomized to two groups: self administration of SC DMPA or clinic administration of SC DMPA. The primary objective of this study is to compare the continuation rates of SC DMPA between the self and clinic administration groups at 6 months. Secondary outcomes include participant satisfaction, cost effectiveness of self-injected use of DMPA, baseline predictors of method continuation or discontinuation, evidence of persistent skin changes following administration of SC DMPA, and need for continued clinical support.
This is the only study on the registry with Carolyn L. Westhoff as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Self administration of subcutaneous depot medroxyprogesterone acetate
Drug: Medroxyprogesterone 17-Acetate
Clinic administration (routine care) of DMPA
Drug: Medroxyprogesterone 17-Acetate
Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
Also known as: depo-subQ 104
Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
Also known as: depo-subQ 104
Number of Participants Continuing DMPA at 6 Months
The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA
Time frame: 6 months
Number of Participants Continuing DMPA
The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints.
Time frame: 3, 9, 12 months
Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available
The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA
Time frame: 6, 12 months
Prevalence of Participants With Persistent Skin Changes
The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)
Time frame: 12 months
Scaled Satisfaction Score
This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.
Time frame: 6, 12 months
Average Minutes Spent Getting Ready for and Giving the Injection
In total, how much time did the participant spend getting ready for and giving the injection. This includes the time the participant spent getting ready to come to the clinic, getting to the appointment, and waiting for the provider for the control group.
Time frame: 0-12 months
| Milestone | Self Administration of DMPA | Clinic Administration of DMPA |
|---|---|---|
| Started | 86 | 46 |
| Completed | 76 | 39 |
| Not completed | 10 | 7 |
| Withdrew: Lost to follow-up | 10 | 6 |
| Withdrew: Withdrawal by subject | 0 | 1 |
The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA
| participants | Self Administration of DMPA | Clinic Administration of DMPA |
|---|---|---|
| Number of Participants Continuing DMPA at 6 Months | 61 | 29 |
The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints.
| Participants | Self Administration of DMPA | Clinic Administration of DMPA |
|---|---|---|
| Number of Participants Continuing DMPA | 61 | 29 |
The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA
No measurements were reported for this outcome.
The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)
No measurements were reported for this outcome.
This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.
No measurements were reported for this outcome.
In total, how much time did the participant spend getting ready for and giving the injection. This includes the time the participant spent getting ready to come to the clinic, getting to the appointment, and waiting for the provider for the control group.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Self Administration of DMPA | — | 0/86 (0%) | 0/86 (0%) |
| Clinic Administration of DMPA | — | 0/46 (0%) | 0/46 (0%) |
| Age, Continuous(years) | Self Administration of DMPA | Clinic Administration of DMPA | Total |
|---|---|---|---|
| Mean | 26 ± 6.1 | 26.1 ± 6.3 | 26.03 ± 6.2 |
| Sex: Female, Male(Participants) | Self Administration of DMPA | Clinic Administration of DMPA | Total |
|---|---|---|---|
| Female | 86 | 46 | 132 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Self Administration of DMPA | Clinic Administration of DMPA | Total |
|---|---|---|---|
| United States | 86 | 46 | 132 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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