A Phase I Study to Evaluate the PK and PD of a Single Injection of Levonorgestrel Butanoate for Female Contraception

NCT02173808 | Completed Phase 1

• 1 other identifier: CCN011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the levonorgestrel (LNG) pharmacokinetic (PK) profile following injection of a single 20 mg dose of levonorgestrel butanoate (LB).

Conditions

Contraceptive Usage

Outcome Measures

Primary Outcomes (1)

• PK profile will be assessed in terms of the pharmacodynamics profile that correlates with the goal of reversible female contraception.

  PK profile will be assessed in terms of the pharmacodynamics profile that correlates with the goal of reversible female contraception. For each subject and for the low and high BMI groups, the primary endpoint will be the time to return of ovulation based on two consecutive serum progesterone \>3 ng/L or a single progesterone \>10 ng/L.

  May 2011 - June 2012 (13 months)

Secondary Outcomes (6)

• Assessing the pharmacodynamics (PD) profile through evaluation of endometrial thickness, ovarian follicular development, cervical mucus changes, steroid hormones, gonadotropins and sex hormone binding globulin.

  May 2011 - June 2012 (13 months)

• Assessing the pharmacodynamics (PD) profile through evaluation of ovarian follicular development.

  May 2011 - June 2012 (13 months)

• Assessing the pharmacodynamics (PD) profile through evaluation of cervical mucus changes.

  May 2011 - June 2012 (13 months)

• Assessing the pharmacodynamics (PD) profile through evaluation of steroid hormones.

  May 2011 - June 2012 (13 months)

• Assessing the pharmacodynamics (PD) profile through evaluation of gonadotropins.

  May 2011 - June 2012 (13 months)

Study Arms (1)

Contraceptive

EXPERIMENTAL

Biological: levonorgestrel butanoate

Interventions

levonorgestrel butanoate BIOLOGICAL

Contraceptive

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health
• Aged 18-44 years, inclusive, at the enrollment visit
• Intact uterus with at least one ovary
• Serum progesterone value ≥ 3 ng/mL at the Screening Visit (V0-P)
• Pap test within the last 12 months or undergo a Pap test at screening prior to enrollment. If a potential subject states that she has had a Pap test within the last 12 months, then she will need to provide documentation of acceptable test results
• Cervical mucus score of \>7, which is based on the modified Insler scoring system during the screening cycle. The cervical mucus is collected by aspiration and the assessment is based on the modified Insler scoring system (the volume and pH of the mucus are not included in the total scoring) yielding a total possible score of 12 (3, 4)
• Regular menstrual cycles that occur every 24 - 35 days
• If subject is postpartum or post-abortal (with abortion in second trimester), she will be required to have two normal menstrual cycles prior to screening
• If subject had an abortion in the first trimester, she will be required to have at least one menstrual cycle (two menses) prior to screening
• Heterosexually abstinent or, if heterosexually active, must have undergone previous tubal sterilization, be in monogamous relationship with a vasectomized partner, or only use male or female condoms (use of condoms that are pre-lubricated with or without spermicide is acceptable) for the entire duration of the study. Use of a spermicide applied separately is not allowed. Cervical caps or diaphragms are not allowed during study participation
• In the opinion of the investigator, able to comply with the protocol, willing to record requested information in the daily diary, and live within the study site catchment area or within a reasonable distance from the site
• Understand and sign an IRB approved informed consent form prior to screening activities (including fasting blood draw)
• Willing to refrain from use of any vaginal creams, lubricants, gels, or spermicides for 3 days prior to study admission through to the end of the study
• Agree not to participate in any other clinical trials during the course of this study

You may not qualify if:

• Known hypersensitivity or contraindication to progestins
• Known or suspected pregnancy
• Prior hysterectomy or bilateral oophorectomy
• Prior cervical surgery (LEEP, Cone biopsy)
• A history (within prior 12 months) of drug or alcohol abuse
• Undiagnosed abnormal genital bleeding
• Undiagnosed vaginal discharge or vaginal lesions or abnormalities. Subjects diagnosed at screening with a Chlamydia or gonococcus infection may not be included in the trial unless they are treated and proof of cure is documented after treatment (i.e. repeat test with negative results). In accordance with PI/medical designee assessment and local standards of practice, women with a history of genital herpes can be included if outbreaks are infrequent. Antiviral prophylactic therapy is permitted
• Uncontrolled thyroid disorder
• Any Pap test finding that would require additional workup or treatment during the study interval. HPV testing will not be done at screening for these subjects
• Use of an injectable hormonal contraceptive (Depo-Provera®) within the past 10 months
• Use of oral contraceptives, contraceptive implants, or other sex steroid hormones within 30 days prior to screening visit
• Women who are breastfeeding or within 30 days of discontinuing breast feeding
• Women planning to undergo major surgery within four months of study enrollment
• Women planning pregnancy within their months of study enrollment
• Current or past deep vein thrombophlebitis or thromboembolic disorders

Sponsors & Collaborators

• Premier Research: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Interventions

levonorgestrel butanoate

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: June 25, 2014
• Study Start: May 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 22, 2016

Record last verified: 2014-04

Locations

US (1)