DEPO-SUBQ PROVERA 104™ (medroxyprogesterone acetate injectable suspension) 104 mg/0.65
mL Indications and Usage
depo-subQ provera 104™ is indicated for the prevention
of pregnancy in women of childbearing potential.
depo-subQ provera 104™ also is indicated for management
of endometriosis-associated pain.
In considering use for either indication, the loss of bone mineral density (BMD)
in women of all ages and the impact on peak bone mass in adolescents should be considered,
along with the decrease in BMD that occurs during pregnancy and/or lactation, in
the risk/benefit assessment for women who use depo-subQ provera 104™
long-term (see WARNINGS, section 1).
Contraception Studies
In three clinical studies, no pregnancies were detected among 2,042 women using
deposubQ provera 104 for up to 1 year. The Pearl Index pregnancy rate in women who
were less than 36 years old at baseline, based on cycles in which they used no other
contraceptive methods, was 0 pregnancies per 100 women-years of use (upper 95% confidence
interval = 0.25).
Pregnancy rates for various contraceptive methods are typically reported for only
the first year of use and are shown in Table 2.
Table 2. Percentage of Women Experiencing an Unintended Pregnancy During the First
Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage
Continuing Use at the End of the First Year: United States
Endometriosis Studies
The efficacy of depo-subQ provera 104™ in the reduction
of endometriosis-associated pain in women with the signs and symptoms of endometriosis
was demonstrated in two active comparator-controlled studies. Each study assessed
reduction in endometriosis-associated pain over 6 months of treatment and recurrence
of symptoms for 12-months post treatment. Subjects treated with depo-subQ provera
104 for 6 months received a 104 mg dose every 3 months (2 injections), while women
treated with leuprolide microspheres for 6 months received a dose of 11.25 mg every
3 months (2 injections) or 3.75 mg every month (6 injections). Study 268 was conducted
in the U.S. and Canada and enrolled 274 subjects (136 on depo-subQ provera 104 and
138 on leuprolide). Study 270 was conducted in South America, Europe and Asia, and
enrolled 299 subjects (153 on depo-subQ provera 104 and 146 on leuprolide).
Reduction in pain was evaluated using a modified Biberoglu and Behrman scale that
consisted of three patient-reported symptoms (dysmenorrhea, dyspareunia, and pelvic
pain not related to menses) and two signs assessed during pelvic examination (pelvic
tenderness and induration). For each category, a favorable response was defined
as improvement of at least 1 unit (severity was assessed on a scale of 0 to 3) relative
to baseline score (Figure 2).
Figure 2. Percentages of Responders at End of Treatment (Month 6 or Last Assessment
if Earlier) in Studies 268 & 270
Additionally, scores from each of the five categories were combined, with the total
(composite score) considered a global measurement of overall disease improvement.
For subjects with baseline scores for each of the 5 categories, a mean decrease
of 4 points relative to baseline was considered a clinically meaningful improvement.
Across both studies, for both treatment groups, the mean changes in the composite
score met the protocol-defined criterion for improvement.
In the clinical trials, treatment with depo-subQ provera 104™
was limited to six months. Data on the persistence of benefit with longer treatment
are not available.
Subjects recorded daily the occurrence and severity of hot flushes. Of the depo-subQ
provera 104™ users, 28.6% reported experiencing moderate
or severe hot flushes at baseline, 36.2% at month 3, and 26.7% at month 6. Of the
leuprolide users, 32.8% reported experiencing moderate or severe hot flushes at
baseline, 74.2% at month 3, and 68.5% at month 6.
- iTrussell J. Contraceptive efficacy. In Hatcher RA, Trussell
J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F, Contraceptive Technology: 17th
Revised Edition. New York, NY: Irvington Publishers, 1998.