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Contraceptive UsagePhase 1CCN011NCT02173808

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

A Phase 1 study testing levonorgestrel butanoate in people with Contraceptive Usage, run by Premier Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 44 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraceptive Usage
What is being tested?
levonorgestrel butanoate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
May 2011to Jun 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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
  • Smoking in women who are ages 18-44 years old that smoke 15 cigarettes or more per day must be evaluated by the PI for inclusion based on risk factors that would increase their risk for cardiovascular (CVD) and thromboembolism
  • Current or past deep vein thrombophlebitis or thromboembolic disorders
  • History of known thrombophilia in a first-degree relative <45 years of age suggesting familial defect in blood coagulation system, which in the opinion of the principal investigator, suggests use of a hormonal contraceptive could pose a significant risk
  • Cerebrovascular or cardiovascular disease or increased risk for arterial thrombosis
  • History of retinal vascular lesions, unexplained partial or complete loss of vision
  • Known or suspected carcinoma of the breast, endometrium, or any other known or suspected progestin-dependent neoplasia
  • Past history of any other carcinoma (excluding basal cell carcinomas) unless in remission for more than 5 years
  • Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive, unless she is stable on antidepressant medication
  • Headaches with focal neurological symptoms only in women over 35 years old
  • History of cholestatic jaundice of pregnancy or jaundice with prior steroid use or other benign or malignant liver tumors; active liver disease
  • Systolic BP > 140 mm Hg and/or Diastolic blood pressure (BP) > 90 mm Hg after 5-10 minutes rest
  • Clinically significant abnormal serum chemistry values according to the Principal Investigator's judgment
  • Participation in another clinical trial involving an investigational drug or device within last 30 days (prior to screening)
  • Use of liver enzyme inducers within last 90 days (prior to screening) or intention to use liver enzyme inducers during the study
  • Known HIV infection
  • Women at high risk of contracting HIV, e.g. women with multiple sex partners who need to use condoms consistently, injection drug users. Women enrolled in the study, who use condoms to protect against STIs or pregnancy, should be instructed that they can use condoms that are pre-lubricated with spermicide or lubricated, but they cannot use a spermicide applied separately and they should record all condom use in their diaries
  • Women who use any medications on the Exclusionary Medication List OR used any within the past three months prior to the screening visit
  • Women with BMI ≥40 kg/m2 are excluded
  • Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health & Science University

    Portland, Oregon

Other trials in United States

About this study

Official title: A Phase I Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profile of a Single Injection of Levonorgestrel Butanoate (LB) for Female Contraception

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

Read the detailed description

This is a Phase I single center, open-label, single dose pharmacokinetic and pharmacodynamic study of an injectable formulation of levonorgestrel butanoate (LB) jointly developed by the National Institute of Child Health and Human Development (NICHD) and CONRAD, and manufactured by Coldstream Laboratories, Inc. Healthy normal weight and obese women will be followed as outpatients for up to eight months. During this study, subjects will undergo a screening cycle to confirm normal ovulatory function, and then receive active treatment with a single injection of LB. They will undergo frequent evaluations to obtain serum samples to evaluate drug levels and ovulatory function, as well as transvaginal ultrasound and cervical mucus evaluation 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 cyclicity within 12- 26 weeks following the injection. Subjects will continue to be followed for one normal cycle after return of menses. This study will be conducted by the NICHD at one of the Contraceptive Clinical Trials Network (CCTN) sites (Oregon Health \& Science University, (OHSU)) in the USA and will enroll approximately 16 women.

This study will enroll approximately 16 subjects that demonstrate favorable cervical mucus and normal ovulatory function during a baseline cycle. Enrollment will be stratified to ensure that 50% of the subjects have a BMI >32 kg/m2 and <40 kg/m2 and approximately 50% of subjects have a BMI <32 kg/m2.

Being tested
levonorgestrel butanoate
Medical subject headings
Contraception Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • levonorgestrel butanoateBiological

Study groups in NCT02173808
Study groupRoleWhat they receive
ContraceptiveExperimentalNot described
Receives: Biological: levonorgestrel butanoate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: May 2011 - June 2012 (13 months)

Secondary outcomes (6)

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

    Measured: May 2011 - June 2012 (13 months)

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

    Measured: May 2011 - June 2012 (13 months)

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

    Measured: May 2011 - June 2012 (13 months)

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

    Measured: May 2011 - June 2012 (13 months)

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

    Measured: May 2011 - June 2012 (13 months)

  6. Assessing the pharmacodynamics (PD) profile through evaluation of sex hormone binding globulin.

    Measured: May 2011 - June 2012 (13 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2014 (estimated)
  2. Study startMay 2011
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02173808
Sponsor's protocol ID
CCN011
Acronym
CCN011
Status last verified
Apr 2014
First submitted
12 May 2014
Last updated
22 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing levonorgestrel butanoate in people with Contraceptive Usage, run by Premier Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK profile will be assessed in terms of the pharmacodynamics profile that correlates with the goal of reversible female contraception. (time frame: May 2011 - June 2012 (13 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02173808.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.

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