Lower Dose Depo Provera® Contraceptive Injection

Contraception Clinical Trial

Official title:

A Study to Evaluate Suppression of Ovulation Following a Single Subcutaneous Administration of Various Doses of Depo-Provera CI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732418
• Other study ID #: 834119
• Status: Completed
• Phase: Phase 1
• Start date: December 2, 2016
• Est. completion date: May 15, 2018

Study information

• Verified date: June 2018
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Depo-Provera CI
The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA)
• 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

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Campinas (UNICAMP)	CAmpinas
Chile	Instituto Chileno De Medicina Reproductiva (ICMER)	Santiago
Dominican Republic	Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
FHI 360

Countries where clinical trial is conducted

Brazil,  Chile,  Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of serum MPA concentrations	Measure of Peak Concentrations (Cmax)	32 weeks after receiving drug
Secondary	Time to maximum serum concentration of MPA	Time to reach peak concentration of MPA(Tmax)	32 weeks after receiving drug
Secondary	Occurrence of adverse events		32 weeks after receiving drug