Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

NCT02456584 | Completed Phase 1 FDA Drug

• 1 other identifier: 702179
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 2

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.

Conditions

Contraception

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Measure of time to ovulation

  up to 18 months

Secondary Outcomes (20)

• Cmax

  up to 18 months

• Aggregate of individual Cmax measurements and parameters

  up to 18 months

• Type and frequency of adverse events

  up to 18 months

• Blood pressure at follow up

  up to 18 months

• Pulse at follow up

  up to 18 months

Study Arms (3)

DMPA 150

EXPERIMENTAL

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

Drug: DMPA 150

DMPA 300

EXPERIMENTAL

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

Drug: DMPA 300

DMPA 104

ACTIVE COMPARATOR

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

Drug: DMPA 104

Interventions

DMPA 150 DRUG

injectable contraceptive

Also known as: Depo-Provera® CI (150mg/mL, intramuscular)

DMPA 150

DMPA 300 DRUG

injectable contraceptive

Also known as: Depo-Provera® CI (300mg/2mL, intramuscular)

DMPA 300

DMPA 104 DRUG

injectable contraceptive

Also known as: depo-subQ provera 104® (104mg/0.65mL, sub-cutaneous)

DMPA 104

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• FHI 360: lead
• Oregon Health and Science University: collaborator
• Asociación Dominicana Pro Bienestar de la Familia, Inc.: collaborator

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)

Santo Domingo, Dominican Republic

Location

Related Publications (1)

• Halpern V, Brache V, Taylor D, Lendvay A, Cochon L, Jensen JT, Dorflinger LJ. Clinical trial to evaluate pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after subcutaneous administration of Depo-Provera. Fertil Steril. 2021 Apr;115(4):1035-1043. doi: 10.1016/j.fertnstert.2020.11.002. Epub 2021 Jan 21.

  PMID: 33485608 DERIVED

MeSH Terms

Interventions

Injections, Intramuscular; Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Vera Halpern, MD

  FHI 360

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 28, 2015
• Study Start: September 1, 2015
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); DO (1)