Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

NCT ID: NCT02456584

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-08-30

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

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

DMPA 150

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

Group Type: EXPERIMENTAL

DMPA 150

Intervention Type: DRUG

injectable contraceptive

DMPA 300

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

Group Type: EXPERIMENTAL

DMPA 300

Intervention Type: DRUG

injectable contraceptive

DMPA 104

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

Group Type: ACTIVE_COMPARATOR

DMPA 104

Intervention Type: DRUG

injectable contraceptive

Interventions

DMPA 150

injectable contraceptive

Intervention Type: DRUG

DMPA 300

injectable contraceptive

Intervention Type: DRUG

DMPA 104

injectable contraceptive

Intervention Type: DRUG

Other Intervention Names

Depo-Provera® CI (150mg/mL, intramuscular); Depo-Provera® CI (300mg/2mL, intramuscular); depo-subQ provera 104® (104mg/0.65mL, sub-cutaneous)

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Asociación Dominicana Pro Bienestar de la Familia, Inc.

OTHER

Sponsor Role: collaborator

FHI 360

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vera Halpern, MD

Role: STUDY_DIRECTOR

FHI 360

Locations

Oregon Health & Science University

Portland, Oregon, United States

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

Santo Domingo, , Dominican Republic

Countries

United States; Dominican Republic

References

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.

Reference Type: DERIVED

PMID: 33485608 (View on PubMed)

Other Identifiers

702179

Identifier Type: -

Identifier Source: org_study_id