Sayana Press is a subcutaneous formulation of medroxyprogesterone acetate, which inhibits the secretion of gonadotrophins, thereby preventing follicular maturation and ovulation. Endometrial thinning also occurs as a result of ovulation suppression. 1
The contraceptive efficacy of medroxyprogesterone acetate (104mg/0.65ml) injected subcutaneously every 3 months was assessed in two phase III open-label non-comparator studies involving 1,787 women aged 18 to 49 years.2
Women recruited to the study were required to be sexually active and included those who had used oral, intrauterine or barrier methods of contraception previously. Women were excluded if they had used any of these contraceptive methods within the 2 months before enrolment or had received an intramuscular injection of medroxyprogesterone within 10 months before enrolment.2
Zero pregnancies at end of year 1
The cumulative pregnancy rate at 1 year (the primary efficacy endpoint) was zero, as was the Pearl Index (number of pregnancies per 100 woman years of use).2
Another phase III, evaluator-blinded study (n=534) compared the contraceptive efficacy and changes in bone mineral density (BMD) associated with medroxyprogesterone acetate given subcutaneously (104mg) or intramuscularly (150mg, as Depo-Provera®) every 3 months for 2 years.3
After 2 years, women had the option to continue in the study for a further year with the same medroxyprogesterone formulation they had been receiving, or to discontinue treatment.3
The cumulative pregnancy rate at 2 years was zero in the subcutaneous group and 0.8% in the intramuscular group (Pearl Indices 0 vs 0.35, respectively). These values remained unchanged at 3 years.3
The observed median BMD decreases from baseline at the total hip and lumbar spine at 2 years and 3 years were slightly smaller in the subcutaneous group than in the intramuscular group (-3.3% vs -3.6%, respectively at the total hip and -4.3% vs .5.0%, respectively at the lumbar spine). However, the differences were not significant.3
Mean weight gain from baseline was similar for women receiving medroxyprogesterone by the subcutaneous or intramuscular routes (3.4kg versus 3.5kg at the end of year 2 and 4.5kg versus 5.8kg at the end of year 3).3
Subcutaneous medroxyprogesterone was well tolerated in all three studies.2,3
- Sayana Press Summary of Product Characteristics, September 2012.
- Jain J et al. Contraception 2004; 70: 269–75.
- Kaunitz AM et al. Contraception 2009; 80: 7–17.
Further information: Pfizer