Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

This is a randomized, multi-center, parallel-group Phase I study with a primary objective to
evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single
subcutaneous (SC) injection of 150mg/mL or 300mg/2mL Depo-Provera CI in the abdomen of women
of reproductive age with a confirmed ovulatory baseline cycle.

Secondary study objectives are:

- To evaluate and compare the pharmacokinetics (PK) of MPA after a single SC injection of
150mg/mL or 300mg/2mL of Depo-Provera CI to two injections of Depo-subQ 104 administered
3 months apart

- To evaluate the relationship between serum MPA concentration and suppression of
ovulation

- To evaluate and compare the safety, tolerability and acceptability of a SC injection of
DMPA of different frequencies, doses and volumes

inclusion

Women may be included in the study if they meet all of the following criteria:

- in good general health

- age 18 to 40 years, inclusive

- willing to provide informed consent and follow all study requirements

- not pregnant

- does not desire to become pregnant in the next 24 months

- regular menstrual cycle (24 to 35 days)

- confirmed ovulation by serum P ≥ 4.7 ng/mL in two consecutive samples during the
pre-treatment phase of the study

- at low risk of pregnancy (e.g., sterilized, in exclusively same sex partnership, in
monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD
or condoms)

- has a body mass index of 18.0 to 35.0

- has hemoglobin ≥10.5 g/L

exclusion

Women will be excluded from participating in this study if they meet any of the following
criteria:

- medical contraindications to DMPA use

- use of any of the following medications within 1 month prior to enrollment:

- any investigational drug

- prohibited drugs (per protocol)

- oral contraceptives

- LNG IUS or implant

- use of DMPA in the past 12 months

- use of a combined injectable contraceptive in the past 6 months

- recent pregnancy (within 3 months)

- current lactation

- ongoing or anticipated use of prohibited drugs (per protocol)

- known sensitivity to MPA

- plan to move to another location in the next 18 months

- any condition (social or medical) which in the opinion of the site investigator would
make study participation unsafe, would interfere with adherence to study requirements
or complicate data interpretation.