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Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle

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ClinicalTrials.gov Identifier: NCT02817464
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
FHI 360
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. )

Brief Summary:
The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive effect when injected every 6 months.

Condition or disease Intervention/treatment Phase
Pregnancy Contraception Drug: TV-46046 - 400 mg/mL Drug: TV-46046 - 200 mg/mL Drug: TV-46046 - 300 mg/mL (if warranted) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Two-part, Phase 1, Exploratory and Dose-range Finding Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following a Single Subcutaneous Administration of TV-46046 in Women With Ovulatory Cycle
Actual Study Start Date : October 7, 2016
Actual Primary Completion Date : December 3, 2018
Actual Study Completion Date : December 3, 2018

Arm Intervention/treatment
Experimental: TV-46046 - 1 Drug: TV-46046 - 400 mg/mL
A single subcutaneous injection in the abdomen of TV-46046 - 400 mg/mL

Experimental: TV-46046 - 2 Drug: TV-46046 - 200 mg/mL
A single subcutaneous injection in the abdomen of TV-46046 - 200 mg/mL

Experimental: TV-46046 - 3 Drug: TV-46046 - 300 mg/mL (if warranted)
A single subcutaneous injection in the abdomen of TV-46046 - 300 mg/mL (if warranted)




Primary Outcome Measures :
  1. Serum progesterone concentration [ Time Frame: Baseline, Days: 1, 2, 4, 6, 8, 10, 12; then weekly through week 52 ]
  2. Serum Medroxyprogesterone acetate (MPA) concentration [ Time Frame: Baseline, Days: 1, 2, 3, 5, 7, 10, 12, 14, 18, 20; 28, 35, 42; then at weeks 8, 10, 12, 13, 15, 17, 19, 21, 23, 25, 26, 28, 30, and 32; and then every 28 days until week 52 (in Part 1) ]
  3. Observed serum drug concentration at day 182 (Cmax) [ Time Frame: Baseline, Days: 1, 2, 3, 5, 7, 10, 12, 14, 18, 20; 28, 35, 42; weeks 8, 10, 12, 13, 15, 17, 19, 21, 23, 25, 26, 28, 30, and 32; and then every 28 days until week 52. ]
  4. Observed serum drug concentration (tmax) [ Time Frame: Baseline, Days: 1, 2, 3, 5, 7, 10, 12, 14, 18, 20; 28, 35, 42; weeks 8, 10, 12, 13, 15, 17, 19, 21, 23, 25, 26, 28, 30, and 32; and then every 28 days until week 52. ]
  5. Area under the serum drug concentration by time curve from time 0 to day 182 (AUC0-182) [ Time Frame: Baseline, Days: 1, 2, 3, 5, 7, 10, 12, 14, 18, 20; 28, 35, 42; weeks 8, 10, 12, 13, 15, 17, 19, 21, 23, 25, 26, 28, 30, and 32; and then every 28 days until week 52. ]
  6. Area under the concentration time-curves (AUC0-∞) [ Time Frame: Baseline, Days: 1, 2, 3, 5, 7, 10, 12, 14, 18, 20; 28, 35, 42; weeks 8, 10, 12, 13, 15, 17, 19, 21, 23, 25, 26, 28, 30, and 32; and then every 28 days until week 52. ]
  7. Apparent terminal half-life [ Time Frame: Baseline, Days: 1, 2, 3, 5, 7, 10, 12, 14, 18, 20; 28, 35, 42; weeks 8, 10, 12, 13, 15, 17, 19, 21, 23, 25, 26, 28, 30, and 32; and then every 28 days until week 52. ]

Secondary Outcome Measures :
  1. Observed serum drug concentration (Cmax) [ Time Frame: Day 7, week 13, 32, 78 ]
  2. Time to observed serum drug concentration (tmax) [ Time Frame: Day 7, week 13, 32, 78 ]
  3. Observed serum drug concentration at day 210 (C210) [ Time Frame: Day 7, week 13, 32, 78 ]
  4. Observed serum drug concentration at day 182 (C182) [ Time Frame: Day 7, week 13, 32, 78 ]
  5. Area under the serum drug concentration by time curve from time 0 to day 182 (AUC0-182) [ Time Frame: Day 7, week 13, 32, 78 ]
  6. Area under the plasma/serum drug concentration by time curve from time 0 to day 210 (AUC0-210) [ Time Frame: Day 7, week 13, 32, 78 ]
  7. Area under the concentration time-curves from time zero (AUC0-∞) [ Time Frame: Day 7, week 13, 32, 78 ]
  8. Percentage of Participants with Adverse Events [ Time Frame: 78 weeks ]


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 regular menstrual cycle (24 to 35 days)
  • is at low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, in monogamous relationship with vasectomized partner, or using non-hormonal IUD)
  • is in good general health as determined by a medical history and physical examination
  • is not pregnant and does not have desire to become pregnant in the subsequent 36 months
  • has had a normal mammogram within the last year (for Part 1 only)

    • additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • has hypertension:

    • systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg
    • vascular disease
  • has current or history of ischemic heart disease
  • has history of stroke
  • has history of thromboembolic event
  • has systemic lupus erythematosus

    • positive (or unknown) antiphospholipid antibodies
    • severe thrombocytopenia
  • has rheumatoid arthritis on immunosuppressive therapy
  • has migraine with aura
  • has unexplained vaginal bleeding
  • has diabetes
  • has strong family history of breast cancer (defined as one or more first degree relatives, breast cancer occurring before menopause in three or more family members, regardless of degree of relationship, and any male family member with breast cancer), or current or history of breast cancer, or undiagnosed mass detected by breast exam
  • has current or history of cervical cancer
  • has severe cirrhosis (decompensated) or liver tumors
  • has known significant renal disease
  • used Depo-Provera Contraceptive Injection or Depo-subcutaneous Provera 104 (DMPA) products in the past 12 months
  • used any of the following medications within 1 month prior to enrollment:

    • any investigational drug
    • prohibited drugs per protocol
    • oral contraceptives, contraceptive ring or patch
    • levonorgestrel intrauterine system (LNG IUS) or contraceptive implant
  • used a combined injectable contraceptive in the past 6 months
  • less than 3 months since the end of last pregnancy
  • currently lactating
  • is using or plans to use prohibited drugs per protocol in the next 18 months
  • has known sensitivity to MPA or inactive ingredients
  • has a plan to move to another location in the next 24 months
  • in the opinion of the investigator, potentially at elevated risk of HIV infection (eg, HIV -positive partner, IV drug use by self or by partner)

    • additional criteria apply, please contact the investigator for more information

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): NCT02817464


Locations
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United States, Pennsylvania
Teva Investigational Site 001
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Teva Investigational Site 002
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
FHI 360
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT02817464    
Other Study ID Numbers: TV46046-WH-10075
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No