Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborating Sponsors:
FHI 360
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate and compare the pharmacokinetic profile of Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of TV-46046 and a d...
Eligibility Criteria
Inclusion
- has regular menstrual cycle (21 to 35 days)
- has a low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, abstinent, in monogamous relationship with vasectomized partner, using nonhormonal intrauterine device (IUD), or consistently using barrier methods of contraception)
- had a normal mammogram within the last year, if 40 years of age or older
- NOTE- Additional criteria apply, please contact the investigator for more information.
Exclusion
- has multiple risk factors for cardiovascular disease (eg, smoking, obesity, hypertension, known low HDL, high LDL, or high triglyceride levels)
- has current or history of ischemic heart disease
- has active thrombophlebitis, current or past history of thromboembolic disorders, cerebral vascular disease or stroke
- has systemic lupus erythematosus
- has rheumatoid arthritis on immunosuppressive therapy
- has unexplained vaginal bleeding
- has diabetes
- has strong family history of breast cancer (defined as one or more first degree relatives with breast cancer, breast cancer occurring before menopause in three or more family members, regardless of degree of relationship, and any male family member with breast cancer)
- has current or history of breast cancer, or undiagnosed mass detected by breast exam
- has current or history of cervical cancer
- has cirrhosis or liver tumors
- has known osteoporosis or osteopenia
- has history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt, except short-lived situational depression that did not require medication and has not recurred in last five years
- used MPA-containing injectable products 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
- oral contraceptives, contraceptive ring or patch
- levonorgestrel intrauterine system (LNG IUS) or contraceptive implant
- is participating in another clinical trial
- is pregnant
- desires to become pregnant in subsequent 24 months
- has been pregnant in last 3 months
- is currently lactating
- NOTE- Additional criteria apply, please contact the investigator for more information.
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04682353
Start Date
December 14 2020
End Date
January 12 2023
Last Update
February 26 2024
Active Locations (3)
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1
Teva Investigational Site 14002
Cypress, California, United States, 90630
2
Teva Investigational Site 14003
San Antonio, Texas, United States, 78209
3
Teva Investigational Site 18001
Santo Domingo, Dominican Republic, 99999