New treatment approved for endometriosis pain.(News)

Subcutaneous medroxyprogesterone acetate has been approved for the treatment of endometriosis-related pelvic pain. It is the first new treatment to be approved for this indication in 15 years.

Depo subQ provera 104 (DMPA-SC), which contains 104 mg medroxyprogesterone acetate, treats endometriosis pain as effectively as leuprolide acetate, but is associated with significantly less bone loss and fewer vasomotor symptoms, according to data provided by Pfizer Inc., which manufactures the agent.

The Food and Drug Administration granted approval for the endometriosis pain indication in March. Depo-subQ provera 104 received FDA approval for use as a contraceptive in December 2004. Pfizer said depo subQ provera 104 would be widely available this month.

Depo subQ provera 104 is a new formulation of medroxyprogesterone acetate, which is the active ingredient in Depo-Provera Contraceptive Injection (medroxyprogesterone acetate injectable suspension), but with 30% less hormone.

Depo subQ provera 104 is available in prefilled syringes each containing 0.65 mL (104 mg) of medroxyprogesterone acetate sterile aqueous suspension.

Administered by subcutaneous injection four times a year (every 12-14 weeks), DMPA-SC halts menstruation, which results in thinner, more compact endometrial tissue, the company said. This in turn halts the growth of endometrial implants, relieving endometriosis-associated pain.

The package insert contains a black box warning concerning possible bone loss: Women who use DMPA-SC may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of depo-subQ provera 104 during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk of osteoporotic fracture in later life. Depo-subQ provera 104 should be used as a long-term birth control method (that is, longer than 2 years) only if other birth control methods are inadequate.