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Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

Pharmacodynamics (Suppression of Ovulation) and Pharmacokinetics Following a Single Subcutaneous Administration of Depo Provera® CI 150 mg/mL, Depo Provera® CI 300 mg/2 mL, or During Two Cycles of Depo-subQ Provera 104®

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02456584
Enrollment
42
Registered
2015-05-28
Start date
2015-09-30
Completion date
2018-08-30
Last updated
2018-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

depot medroxyprogesterone acetate (DMPA), confidence interval (CI), Subcutaneous (sub-Q), Intrauterine device (IUD), Levonorgestrel (LNG), intrauterine system (IUS)

Brief summary

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.

Detailed 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

Interventions

DRUGDMPA 150

injectable contraceptive

DRUGDMPA 300

injectable contraceptive

DRUGDMPA 104

injectable contraceptive

Sponsors

Oregon Health and Science University
CollaboratorOTHER
Asociación Dominicana Pro Bienestar de la Familia, Inc.
CollaboratorOTHER
FHI 360
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Measure of time to ovulationup to 18 months

Secondary

MeasureTime frameDescription
Cmaxup to 18 monthsUp to ovulation or 18 months following injection, whichever comes first
Aggregate of individual Cmax measurements and parametersup to 18 months
Type and frequency of adverse eventsup to 18 months
Blood pressure at follow upup to 18 months
Pulse at follow upup to 18 months
Weight at follow upup to 18 months
Measure of delayed return to ovulationup to 18 months
Serum concentrations of cortisol7.5 months
Product acceptabilityup to 18 months
Number of participants with Injection site reactionsup to 18 months
Aggregate of individual Tmax measurements and parametersUp to 18 months
MPA concentration at Day 91 (C91)91 days after injection
Aggregate of individual C91 measurements and parameters18 months after injection
MPA concentration at Day 182 (C182)182 days after injection
Aggregate of individual C182 measurements and parameters18 months after injection
MPA concentration at Day 210 (C210)210 days after injection
Aggregate of individual C210 measurements and parameters18 months after injection
Area under the curve (AUC 0-182)182 days after injection
Terminal elimination half-life (t1/2)up to 18 monthsUp to ovulation or 18 months following injection, whichever comes first
Tmaxup to 18 monthsUp to ovulation or 18 months following injection, whichever comes first

Countries

Dominican Republic, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026