Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-26

Study Completion Date

2018-12-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04682353

Contraception

COMPLETED PHASE1

A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception

NCT04143659

Healthy Women Female Contraception

ACTIVE_NOT_RECRUITING PHASE1

PK of Depo SubQ Injected in the Upper Arm

NCT01143207

Contraception

COMPLETED NA

Lower Dose Depo Provera® Contraceptive Injection

NCT02732418

Contraception

COMPLETED PHASE1

Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

NCT02456584

Contraception

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Contraception

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TV-46046 - 1

Group Type EXPERIMENTAL

TV-46046 - 400 mg/mL

Intervention Type DRUG

A single subcutaneous injection in the abdomen of undiluted TV-46046 - 400 mg/mL

TV-46046 - 2

Group Type EXPERIMENTAL

TV-46046 - 200 mg/mL

Intervention Type DRUG

A single subcutaneous injection in the abdomen of saline-diluted TV-46046 - 200 mg/mL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TV-46046 - 400 mg/mL

A single subcutaneous injection in the abdomen of undiluted TV-46046 - 400 mg/mL

Intervention Type DRUG

TV-46046 - 200 mg/mL

A single subcutaneous injection in the abdomen of saline-diluted TV-46046 - 200 mg/mL

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

* additional criteria apply, please contact the investigator for more information

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes