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

2019-11-03 15:10:55 | BioPortfolio

Summary

This is a Phase I multicenter, open-label, dose-ranging, two-dose PK and PD study of injectable LB at administered as a SQ or IM injection at 40 mg and subsequently at 80 mg SQ or IM depending on the pharmacokinetic and pharmacodynamic results obtained at 40 mg.

Description

This is a Phase I multicenter, open-label, dose-ranging, two-dose PK and PD study of injectable LB at administered as a SQ or IM injection at 40 mg and subsequently at 80 mg SQ or IM depending on the pharmacokinetic and pharmacodynamic results obtained at 40 mg.

Healthy normal weight and healthy obese women will be enrolled and followed as outpatients until return to ovulation and normal menses. The participation time is estimated to be up to nine months. During this study, subjects will undergo a screening period prior to enrollment to confirm normal ovulatory function, and then receive active treatment with injection of LB administered via IM or SQ injection. A dose of LB administered IM (40 mg) or SQ (40 mg) was selected for initial evaluation for this study. Once preliminary pharmacokinetic and pharmacodynamic results are available for the 40 mg dose groups, a decision will be made whether to move forward with 80 mg LB administered IM and/or SQ.

Subjects will undergo frequent study and safety evaluations and will have serum samples taken to evaluate drug levels and ovulatory function, in addition to a transvaginal ultrasound (TVUS) at selected visits. Follow up will continue until normal ovulatory cycles resume. Based upon detailed studies in non-human primates, it is expected that most subjects will resume menstrual cycles within 12 - 26 weeks after the injection. Subjects will continue to be followed for one normal cycle after return of menses.

This dose-ranging, PK/PD study will be conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at seven of the female Contraceptive Clinical Trials Network (CCTN) sites in the U.S. and will enroll approximately 128 women who demonstrate normal ovulatory function during the baseline cycle. Enrollment will be stratified to target that 50% of the subjects have a BMI >30 kg/m^2 and <40 kg/m^2 and approximately 50% of subjects have a BMI <30 kg/m^2 in each dose group.

LB injections will be administered at the study site by a trained research nurse or physician. The SQ injections should be done slowly under the skin in the abdomen to ensure drug is dispensed into the tissue layer between the skin and the muscle following standard procedures for subcutaneous injections. For IM injections, the staff should inject LB slowly in the deltoid avoiding the injection into blood vessels following standard procedures for intramuscular injections. (The SQ injection may be given in a different location than the abdomen and the IM injection in a different location than the deltoid with the approval of the Medical Monitor.) The study subject will be observed for at least 30 minutes after the injection before release from the study site.

The different combinations of doses and methods of administration (IM or SQ) will be given in sequential stages, as described below. Individual subjects may only participate in one stage.

Enrollment Stage A: 40 mg IM (32 subjects [16 with BMI <30 kg/m^2; 16 with BMI >30 kg/m^2 and <40 kg/m^2]) Enrollment Stage B: 40 mg SQ (32 subjects [16 with BMI <30 kg/m^2; 16 with BMI >30 kg/m^2 and <40 kg/m^2]) Enrollment Stage C: 80 mg IM (32 subjects [16 with BMI <30 kg/m^2; 16 with BMI >30 kg/m^2 and <40 kg/m^2]) Enrollment Stage D: 80 mg SQ (32 subjects [16 with BMI <30 kg/m^2; 16 with BMI >30 kg/m^2 and <40 kg/m^2])

Stages will be performed sequentially; PK/PD assessments will be performed. The target numbers for enrollment in each BMI category are approximate.

Once preliminary PK/PD results are available for the IM and SQ 40 mg dose, a decision will be made for whether to move forward with 80 mg LB administered IM (Stage C) and/or SQ (Stage D).

Study Design

Conditions

Healthy Women

Intervention

levonorgestrel butanoate (LB) injection

Location

University of California, Davis
Davis
California
United States
95817

Status

Not yet recruiting

Source

Health Decisions

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-03T15:10:55-0500

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