Study of Self or Clinic Administration of DepoProvera

NCT ID: NCT01019369

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Self Administration of DMPA

Self administration of subcutaneous depot medroxyprogesterone acetate

Group Type: EXPERIMENTAL

Medroxyprogesterone 17-Acetate

Intervention Type: DRUG

Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year

Clinic administration of DMPA

Clinic administration (routine care) of DMPA

Group Type: ACTIVE_COMPARATOR

Medroxyprogesterone 17-Acetate

Intervention Type: DRUG

Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year

Interventions

Medroxyprogesterone 17-Acetate

Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year

Intervention Type: DRUG

Medroxyprogesterone 17-Acetate

Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year

Intervention Type: DRUG

Other Intervention Names

depo-subQ 104; depo-subQ 104

Eligibility Criteria

Inclusion Criteria

1. age greater than or equal to 18 years

2. seeking DMPA for contraception

3. English or Spanish speaking

4. consistent access to a working telephone

5. availability for follow up for one year

Exclusion Criteria

1. suspected or continuing pregnancy

2. undiagnosed vaginal bleeding

3. known or suspected breast cancer

4. acute liver disease

5. known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA

6. desire for pregnancy within one year

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Family Planning Fellowship

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Carolyn L. Westhoff

OTHER

Sponsor Role: lead

Responsible Party

Carolyn L. Westhoff

Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carolyn Westhoff, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Anitra Beasley, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University/New York Presbyterian Hospital

New York, New York, United States

Countries

United States

References

Beasley A, White KO, Cremers S, Westhoff C. Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate. Contraception. 2014 May;89(5):352-6. doi: 10.1016/j.contraception.2014.01.026. Epub 2014 Feb 7.

Reference Type: DERIVED

PMID: 24656555 (View on PubMed)

Other Identifiers

AAAD8306

Identifier Type: -

Identifier Source: org_study_id