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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-14

Study Completion Date

2023-01-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1 - 120 mg/0.4 mL

Group Type EXPERIMENTAL

TV-46046

Intervention Type DRUG

SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)

Group 2 - 180 mg/0.6 mL

Group Type EXPERIMENTAL

TV-46046

Intervention Type DRUG

SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)

Group 3 - 240 mg/0.8 mL

Group Type EXPERIMENTAL

TV-46046

Intervention Type DRUG

SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)

Group 4 - 104 mg/0.65 mL

Group Type ACTIVE_COMPARATOR

Depo-subQ Provera

Intervention Type DRUG

SC injection of 104 mg/0.65 mL

Interventions

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TV-46046

SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)

Intervention Type DRUG

Depo-subQ Provera

SC injection of 104 mg/0.65 mL

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes