A new highly effective subcutaneous contraceptive injection

A. Jakimiuk

Department of Surgical Gynecology, University School of Medicine, Lublin, Poland (1)

Objectives: To assess the efficacy, safety, and acceptability of a new formulation of depot medroxyprogesterone acetate subcutaneous injection (DMPA-SC) administered every 3 months (12 to 13 weeks).

Design & Methods: This phase 3, open-label, noncomparator, multinational, multicenter 1-year study included sexually active, regularly menstruating women, aged 18 to 49 years. Subjects who received at least 1 dose of study medication constituted the ITT population. Treatment consisted of DMPA-SC (104 mg) injection at 0, 13, 26, and 39 weeks; subjects at selected sites that successfully self-injected in the office were given the option to self-inject at home for injections 3 and 4. The primary endpoint was the treatment failure cumulative pregnancy rate at 1 year. Safety endpoints included the incidence of amenorrhea, irregular bleeding, and adverse events. Satisfaction with treatment was evaluated through a Patient Satisfaction Questionnaire (PSQ) and End of Treatment Questionnaire (EOTQ).

Results: Of the 1065 subjects in the ITT population (mean age, 32.2 years; BMI range, 15.4–40.6 kg/m²), 80.4% completed the study. No pregnancies were reported in this study, which included 10,407 woman-cycles of exposure to DMPA-SC. Efficacy was independent of BMI (overweight, BMI >25 to 30 kg/m², 20.6%; obese, BMI >30 kg/m², 6.3%). At least one home selfinjection was performed by 19.2% of subjects. A very high level of satisfaction with DMPA-SC was indicated in 3 PSQ and EOTQ measures: preferring it to other contraceptive methods, willingness to continue treatment and willingness to recommend it to a friend. The largest percentage (44.0%) of respondents indicated they would prefer home self-injection to injection by clinician (35.5%) or self-injection at the doctor’s office (20.5%). Overall, DMPA-SC was well tolerated. Of the 856 patients assessed at month 12, most subjects (67.1%) either lost weight or fluctuated within a narrow range (-2.29 kg to +2.39 kg). The mean weight gain was 1.4 kg. Most irregular bleeding decreased with time, whereas incidence of amenorrhea increased to 51.6% at month 12. Treatment-emergent side effects leading to discontinuation were low (5.3% of subjects).

Conclusion: The results of this study indicate that new DMPA-SC (104 mg every 12 to 13 weeks) is a highly effective and well-tolerated contraceptive, with efficacy uncompromised by BMI. Subjects reported a high level of satisfaction with DMPA-SC and those given the opportunity for home self-injection preferred this option to injection at the clinician’s office.