Lower Dose Depo Provera® Contraceptive Injection

NCT02732418 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 834119
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 3

Brief Summary

This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle

Conditions

Contraception

Keywords

CI-contraceptive injection; DMPA-Depot medroxyprogesterone acetate; MPA-Medroxyprogesterone Acetate; subQ-subcutaneous

Outcome Measures

Primary Outcomes (1)

• Time to ovulation

  Time to ovulation indicated by time to reach rupture of the lead follicle based on transvaginal ultrasound (TVS) findings followed by serum progesterone level of \>=4.7 ng/mL. The primary objective will be assessed by estimating the cumulative probability of return to ovulation through Month 7.5 from start of therapy in each test group based on the Kaplan-Meier product-limit method, with 95% confidence intervals derived using the complementary log-log transformation.

  32 weeks after receiving drug

Secondary Outcomes (3)

• Measurement of serum MPA concentrations

  32 weeks after receiving drug

• Time to maximum serum concentration of MPA

  32 weeks after receiving drug

• Occurrence of adverse events

  32 weeks after receiving drug

Study Arms (4)

Depo-Provera CI 45 mg

EXPERIMENTAL

a single subcutaneous (SC) injection of 45 mg/0.3 mL

Drug: Depo-Provera CI

Depo-Provera CI 75 mg

EXPERIMENTAL

a single subcutaneous (SC) injection of 75 mg/0.5 mL

Drug: Depo-Provera CI

Depo-Provera CI 105 mg

EXPERIMENTAL

a single subcutaneous (SC) injection of 105 mg/0.7 mL

Drug: Depo-Provera CI

Depo-subQ 104

ACTIVE COMPARATOR

a single subcutaneous (SC) injection of 104 mg/0.65 mL

Drug: Depo-subQ 104

Interventions

Depo-Provera CI DRUG

The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA)

Also known as: Depo Provera® Contraceptive Injection

Depo-Provera CI 105 mg; Depo-Provera CI 45 mg; Depo-Provera CI 75 mg

Depo-subQ 104 DRUG

The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA). Depo-subQ provera 104® (medroxyprogesterone acetate injectable suspension, 104 mg/0.65mL) for subcutaneous injection

Also known as: depo-subQ provera 104®

Depo-subQ 104

Eligibility Criteria

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

You may qualify if:

• has typical menstrual cycle of 24 to 35 days
• has confirmed ovulatory cycle during the pretreatment phase (serum progesterone ≥ 4.7 ng/mL in 2 consecutive samples)
• is sterilized or using non hormonal intrauterine device (IUD)
• is in good general health as determined by a medical history and physical examination
• to 40 years of age (inclusive)
• willing to provide informed consent and follow all study requirements
• has negative urine pregnancy test and has no desire to become pregnant in the subsequent 12 months
• has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
• has hemoglobin ≥10.5 g/dL

You may not qualify if:

• has medical contraindications to depot medroxyprogesterone acetate (DMPA) \[16\]
• has undiagnosed mass in breast
• used DMPA in the past 12 months
• used a combined injectable contraceptive in the past 6 months
• used any of the following medications within 1 month prior to enrollment:
• any investigational drug
• prohibited drugs per protocol
• oral contraceptives
• Nuva-ring
• contraceptive patch
• levonorgestrel intrauterine system (LNG IUS) or contraceptive implant
• has been pregnant within last 3 months
• Is currently lactating
• in the opinion of the investigator, is potentially at elevated risk of HIV infection (HIV-positive partner, IV drug use by self or by partner)
• has more than one male sexual partner

Sponsors & Collaborators

• FHI 360: lead

Study Sites (3)

Universidade Estadual de Campinas (UNICAMP)

Campinas, Brazil

Location

Instituto Chileno De Medicina Reproductiva (ICMER)

Santiago, Chile

Location

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

Santo Domingo, Dominican Republic

Location

MeSH Terms

Interventions

Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Vera Halpern, MD

  FHI 360

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 8, 2016
• Study Start: December 2, 2016
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1); BR (1); CL (1)