Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle
- Conditions
- PregnancyContraception
- Interventions
- Drug: TV-46046 - 400 mg/mLDrug: TV-46046 - 200 mg/mL
- Registration Number
- NCT02817464
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 12
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TV-46046 - 1 TV-46046 - 400 mg/mL - TV-46046 - 2 TV-46046 - 200 mg/mL -
- Primary Outcome Measures
Name Time Method Part 1: Apparent Terminal Half-life (t1/2) of MPA Day 0 up to Week 52 Part 1: Serum MPA Concentration at Day 182 Day 182 Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 210 (AUC0-210) of MPA Day 0 up to Day 210 Part 1: Serum MPA Concentration at Day 7 Day 7 Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 182 (AUC0-182) of MPA Day 0 up to Day 182 Part 1: Serum MPA Concentration at Day 91 Day 91 Part 1: Observed Serum Drug Concentration at Day 182 (C182) of MPA Day 182 Part 1: Time to Reach Cmax (Tmax) of MPA Day 0 up to Week 52 Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Infinity (AUC0-∞) of MPA Day 0 up to Week 52 Part 1: Serum Medroxyprogesterone Acetate (MPA) Concentration at Day 1 Day 1 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Part 1: Serum MPA Concentration at Day 28 Day 28 Part 1: Serum MPA Concentration at Day 210 Day 210 Part 1: Maximum Observed Serum Concentration (Cmax) of MPA Day 0 up to Week 52 Part 2: Time to Ovulation Day 0 up to Week 78 Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL.
- Secondary Outcome Measures
Name Time Method Part 2: Cmax of MPA Day 0 up to Week 52 Part 2: Observed Serum Drug Concentration at Day 210 (C210) of MPA Day 0 up to Day 210 Part 2: C182 of MPA Day 0 up to Day 182 Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Day 0 up to Week 78 An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Part 1: Time to Ovulation Day 0 up to Week 78 Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL. Time to ovulation was computed as the difference in days between detection of the first post-randomization elevated progesterone and the date of treatment initiation. Median time to ovulation was derived using Kaplan-Meier estimate.
Part 2: Tmax of MPA Day 0 up to Week 52 Part 2: AUC0-∞ of MPA Day 0 up to Week 52 Part 2: AUC0-182 of MPA Day 0 up to Day 182 Part 2: Apparent Terminal Half Life (t1/2) of MPA Day 0 up to Week 52 Part 2: AUC0-210 of MPA Day 0 up to Day 210
Trial Locations
- Locations (2)
Teva Investigational Site 001
🇺🇸Philadelphia, Pennsylvania, United States
Teva Investigational Site 002
🇺🇸Norfolk, Virginia, United States