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.
