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Lower Dose Depo Provera® Contraceptive Injection

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ClinicalTrials.gov Identifier: NCT02732418
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
FHI 360

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

Condition or disease Intervention/treatment Phase
Contraception Drug: Depo-Provera CI Drug: Depo-subQ 104 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Study to Evaluate Suppression of Ovulation Following a Single Subcutaneous Administration of Various Doses of Depo-Provera CI
Actual Study Start Date : December 2, 2016
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Depo-Provera CI 45 mg
a single subcutaneous (SC) injection of 45 mg/0.3 mL
Drug: Depo-Provera CI
The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA)
Other Name: Depo Provera® Contraceptive Injection

Experimental: Depo-Provera CI 75 mg
a single subcutaneous (SC) injection of 75 mg/0.5 mL
Drug: Depo-Provera CI
The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA)
Other Name: Depo Provera® Contraceptive Injection

Experimental: Depo-Provera CI 105 mg
a single subcutaneous (SC) injection of 105 mg/0.7 mL
Drug: Depo-Provera CI
The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA)
Other Name: Depo Provera® Contraceptive Injection

Active Comparator: Depo-subQ 104
a single subcutaneous (SC) injection of 104 mg/0.65 mL
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
Other Name: depo-subQ provera 104®




Primary Outcome Measures :
  1. Time to ovulation [ Time Frame: 32 weeks after receiving drug ]
    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.


Secondary Outcome Measures :
  1. Measurement of serum MPA concentrations [ Time Frame: 32 weeks after receiving drug ]
    Measure of Peak Concentrations (Cmax)

  2. Time to maximum serum concentration of MPA [ Time Frame: 32 weeks after receiving drug ]
    Time to reach peak concentration of MPA(Tmax)

  3. Occurrence of adverse events [ Time Frame: 32 weeks after receiving drug ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732418


Locations
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Brazil
Universidade Estadual de Campinas (UNICAMP)
CAmpinas, Brazil
Chile
Instituto Chileno De Medicina Reproductiva (ICMER)
Santiago, Chile
Dominican Republic
Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)
Santo Domingo, Dominican Republic
Sponsors and Collaborators
FHI 360
Investigators
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Principal Investigator: Vera Halpern, MD FHI 360

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Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT02732418     History of Changes
Other Study ID Numbers: 834119
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FHI 360:
CI-contraceptive injection
DMPA-Depot medroxyprogesterone acetate
MPA-Medroxyprogesterone Acetate
subQ-subcutaneous
Additional relevant MeSH terms:
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Medroxyprogesterone Acetate
Contraceptive Agents
Medroxyprogesterone
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents