Abstract & Commentary
Subcutaneous DMPA: Is It Time for Home Administration?
By Rebecca H. Allen, MD, MPH
Assistant Professor, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI
Dr. Allen reports no financial relationships relevant to this field of study.
This randomized, controlled trial demonstrates that women are able to self-administer subcutaneous depot medroxyprogesterone acetate at home correctly and without complication.
Beasley A, et al. Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate. Contraception 2014;89:352-356.
The authors conducted a randomized, controlled trial of 137 women comparing self-administration and clinic administration of subcutaneous depot medroxyprogesterone acetate (DMPA, 104 mg) between 2010 and 2011 in New York City. Participants were aged ≥ 18 years, seeking DMPA for contraception, and available for follow-up for 1 year. Exclusion criteria were contraindications to the use of DMPA and women who desired pregnancy within 1 year. Participants were stratified according to never, past, or current use of DMPA and then randomized in a 2:1 ratio to self vs clinic administration. Women randomized to the self-administration arm were given instructions, supervised for their initial injection, and given a packet containing prefilled glass syringes, supplies, a sharps disposal container, and a DMPA calendar giving dates for the next injection. Women were seen at both 6 and 12 months for follow-up and serum medroxyprogesterone acetate (MPA) levels were measured. The primary outcome variable was the continuation rate at 12 months.
In the study, 86 women were randomized to the self-administration group and 46 to the clinic administration group. Of the 132 participants total, 115 (87%) completed follow-up to 12 months. Ten (11.6%) women in the self-administration group and six (13%) in the clinic administration group were lost to follow-up and were considered to have discontinued DMPA in the analysis. The two groups did not differ in terms of age, education, and history of self-injection in the past. At study end, 71% of women in the self-administration group and 63% of women in the clinic administration group were still using DMPA for contraception (P = 0.47). MPA levels were no different between the two groups in continuous users at 6 and 12 months, indicating compliance with the injections.
COMMENTARY
DMPA is an important contraceptive option for women and is highly effective when women are adherent to the injection schedule.1 The failure rate of DMPA when used perfectly is extremely low (< 1%) and is equivalent to intrauterine devices and implants. While not as long-acting as intrauterine devices and implants, DMPA still affords the user a relatively easy method, with only four required injections per year. Although injectable contraceptives are very popular internationally, currently, only 3% of U.S. women use DMPA for contraception.2 DMPA is extremely safe to use and concerns regarding the temporary decrease in bone mineral density during exposure have been overstated. The U.S. Medical Eligibility Criteria for Contraceptive Use rates the use of DMPA as category 1 (no restrictions) in women ages 18-45 and category 2 (benefits outweigh the risks) in younger women.3
Intramuscular DMPA was originally approved for use as a contraceptive in the United States in 1992. Currently, DMPA is available in the United States as a generic 150 mg intramuscular formulation and a branded 104 mg subcutaneous formulation that was released in 2004. In contrast to other subcutaneous injectables like insulin, gonadotropins, and heparin, DMPA is not labeled for self-administration. However, multiple studies have shown that U.S. women would be interested in this option and that returning to clinic every 3 months can be a burden. The Contraceptive Choice Project in St. Louis reported continuation rates of DMPA at 1 year, 2 years, and 3 years to be 56%, 38%, and 28%, respectively.4,5,6 Improving the convenience for women is an important part of increasing continuation rates for DMPA, although bleeding irregularities are still the number one reason for discontinuation.
This randomized, controlled trial demonstrates that women can self-administer DMPA correctly at home by following instructions. This is the first study that measured MPA levels in the participants to confirm adherence. I would have liked to see more information in the report regarding the users’ experience with self-injection and their satisfaction levels. The authors only report that two women in the self-administration arm did not like or had discomfort with the injections. Nevertheless, it would behoove the manufacturer of subcutaneous DMPA to change the labeling with the FDA to allow for self-administration. One issue that may impede access is expense. Currently, the subcutaneous formulation is more expensive than the generic intramuscular formulation. Internationally, the 104 mg dose of subcutaneous DMPA is packaged in a format ideal for self-administration in a product called Sayana® Press. The drug is packaged in a Uniject device, which is a prefilled injection system using a bubble reservoir and ultra-thin needle. If this product were made to be as affordable as intramuscular DMPA, it could drastically change access to highly effective contraception in Africa and Asia, areas with a high unmet need for contraception.7
References
- Winner B, et al. Effectiveness of long-acting reversible contraception. N Engl J Med 2012;366:1998-2007.
- Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 2010;23:
1-44.
- Centers for Disease Control and Prevention. U S. Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR Recomm Rep 2010;59:1-86.
- Peipert JF, et al. Continuation and satisfaction of reversible contraception. Obstet Gynecol 2011;117:1105-1113.
- O’neil-Callahan M, et al. Twenty-four-month continuation of reversible contraception. Obstet Gynecol 2013;122:1083-1091.
- Kaunitz AM, et al. Injectable contraception: Issues and opportunities. Contraception 2014;89:331-334.
- Spieler J. Sayana® Press: Can it be a "game changer" for reducing unmet need for family planning? Contraception 2014;89:335-338.
