A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Contraception

Treatments: Drug: Depo-subQ Provera; Drug: TV-46046

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04682353

TV46046-WH-10159

Details and patient eligibility

About

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 dose of Depo-subQ Provera in healthy female participants.

The secondary objectives of the study are to evaluate and compare the safety, local tolerability, and acceptability of a subcutaneous injection of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants.

The total duration of the study for each participant is expected to be up to 19.5 months.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Group 1 - 120 mg/0.4 mL

Experimental group

Treatment:

Drug: TV-46046

Group 2 - 180 mg/0.6 mL

Experimental group

Treatment:

Drug: TV-46046

Group 3 - 240 mg/0.8 mL

Experimental group

Treatment:

Drug: TV-46046

Group 4 - 104 mg/0.65 mL

Active Comparator group

Treatment:

Drug: Depo-subQ Provera