Clinical trial NCT02732418: Lower Dose Depo Provera® Contraceptive Injection
Official title: A Study to Evaluate Suppression of Ovulation Following a Single Subcutaneous Administration of Various Doses of Depo-Provera CI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraception
Keywords: CI-contraceptive injection
DMPA-Depot medroxyprogesterone acetate
MPA-Medroxyprogesterone Acetate
subQ-subcutaneous
Lead sponsor: FHI 360
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Time to ovulation
timeFrame: 32 weeks after receiving drug
Secondary outcomes:
measure: Measurement of serum MPA concentrations
timeFrame: 32 weeks after receiving drug
measure: Time to maximum serum concentration of MPA
timeFrame: 32 weeks after receiving drug
measure: Occurrence of adverse events
timeFrame: 32 weeks after receiving drug
Other outcomes:
Locations:
city: CAmpinas
country: Brazil
facility: Universidade Estadual de Campinas (UNICAMP)
city: Santiago
country: Chile
facility: Instituto Chileno De Medicina Reproductiva (ICMER)
city: Santo Domingo
country: Dominican Republic
facility: Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)
Study officials:
affiliation: FHI 360
name: Vera Halpern, MD
role: PRINCIPAL_INVESTIGATOR
References: