Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
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)
Exclusion criteria
has hypertension:
has current or history of ischemic heart disease
has history of stroke
has history of thromboembolic event
has systemic lupus erythematosus
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:
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)
Primary purpose
Allocation
Interventional model
Masking
12 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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