Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

FHI 360

Status and phase: Completed; Phase 1

Conditions: Contraception

Treatments: Drug: DMPA 104; Drug: DMPA 150; Drug: DMPA 300

Study type: Interventional

Funder types: Other

Identifiers

NCT02456584

702179

Details and patient eligibility

About

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

Full description

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

Enrollment: 42 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

DMPA 150

Experimental group

Description:

single subcutaneous injection of 150mg/mL of DMPA in the abdomen

Treatment:

Drug: DMPA 150

DMPA 300

Experimental group

Description:

single subcutaneous injection of 300mg/2mL of DMPA in the abdomen

Treatment:

Drug: DMPA 300

DMPA 104

Active Comparator group

Description:

two injections, given at three months intervals, of 104mg/0.65mL of DMPA in the abdomen

Treatment:

Drug: DMPA 104