Clinical trial to evaluate pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after subcutaneous administration of Depo-Provera

Depo-Provera (150 mg) injected subcutaneously suppressed ovulation for 7 months in 21 women with body mass index 18–35 kg/m2, suggesting that it may provide effective contraception when injected every 6 months.

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VOLUME 115, ISSUE 4, P1035-1043

Authors:

Vera Halpern, M.D., Vivian Brache, B.S., Douglas Taylor, Ph.D., Anja Lendvay, M.P.H., Leila Cochón, B.S., Jeffrey T. Jensen, M.D., M.P.H., Laneta J. Dorflinger, Ph.D.

Abstract:

Objective

To evaluate the pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after a single subcutaneous injection in the abdomen of 150 or 300 mg Depo-Provera and compare results to two injections of Depo-SubQ Provera 104 given 3 months apart.


Design

Partially randomized, multicenter, parallel-group study.


Setting

Research unit.


Patient(s)

Forty-two women of reproductive age with confirmed ovulatory cycle and body mass index of 18–35 kg/m2.


Intervention(s)

Women received a single subcutaneous injection of 150 mg (n = 24) or 300 mg (n = 9) of Depo-Provera or two injections of Depo-SubQ Provera 104 (n = 9).


Main Outcome Measure(s)

Suppression of ovulation as measured by progesterone, serum medroxyprogesterone acetate concentrations, and estimated pharmacokinetics parameters.


Result(s)

No ovulations were observed during 7 months after a single injection of 150 or 300 mg Depo-Provera. The 150 mg group had a similar Cmax as observed over two injection cycles of Depo-SubQ Provera 104 and a similar 6-month trough concentration as the 3-month trough of Depo-SubQ Provera 104.


Conclusion(s)

Our pharmacodynamics and pharmacokinetics data provide proof of concept that Depo-Provera (150 mg) may be an effective contraceptive method when injected subcutaneously every 6 months, with up to a 4-week grace period for reinjections.


Clinical Trial Registration Number

NCT02456584.

Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.