Lower Dose Depo Provera® Contraceptive Injection

NCT ID: NCT02732418

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-02
• Study Completion Date: 2018-05-15

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

Detailed Description

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. Baseline ovulation will be confirmed in all women by measuring serum progesterone (P) approximately twice a week during the 2-3 weeks preceding expected menses. Between 48 and 60 participants (12-15 per group) with confirmed ovulation who meet other eligibility criteria will be enrolled and randomized to receive a single SC injection in the abdomen of 1 of 3 doses of Depo-Provera CI: 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL or a single dose of Depo-subQ Provera (104 mg/0.65mL). Participants will be followed for 32 weeks (7.5 months) after the injection During the study participants will provide blood samples for MPA, P and estradiol (E2) prior to injection and then frequently at predefined time points through 7.5 months. In addition, for more accurate ascertainment of the PD response we will perform transvaginal ultrasound (TVS) and assess cervical mucus at predefined time points through 7.5 months. Information on adverse events and concomitant medications will be collected throughout the study. Information on acceptability will be collected at predefined time points through 7.5 months.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Depo-Provera CI 45 mg

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

Group Type: EXPERIMENTAL

Depo-Provera CI

Intervention Type: DRUG

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

Depo-Provera CI 75 mg

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

Group Type: EXPERIMENTAL

Depo-Provera CI

Intervention Type: DRUG

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

Depo-Provera CI 105 mg

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

Group Type: EXPERIMENTAL

Depo-Provera CI

Intervention Type: DRUG

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

Depo-subQ 104

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

Group Type: ACTIVE_COMPARATOR

Depo-subQ 104

Intervention Type: 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

Interventions

Depo-Provera CI

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

Intervention Type: DRUG

Depo-subQ 104

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

Intervention Type: DRUG

Other Intervention Names

Depo Provera® Contraceptive Injection; depo-subQ provera 104®

Eligibility Criteria

Inclusion Criteria

• 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
• 18 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

Exclusion Criteria

• 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
• is using or plans to use prohibited drugs per protocol in the next 9 months
• has known sensitivity to MPA
• plans to move to another location in the next 9 months
• has any condition (social or medical), which in the opinion of the investigator would make study participation unsafe, would interfere with adherence to the clinical study requirements or complicate data interpretation

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

Sponsors

FHI 360

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vera Halpern, MD

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Locations

Universidade Estadual de Campinas (UNICAMP)

Campinas, , Brazil

Instituto Chileno De Medicina Reproductiva (ICMER)

Santiago, , Chile

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

Santo Domingo, , Dominican Republic

Countries

Brazil; Chile; Dominican Republic

Other Identifiers

834119

Identifier Type: -

Identifier Source: org_study_id