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Trial record 69 of 403 for:    LEVONORGESTREL

Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics

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ClinicalTrials.gov Identifier: NCT02531321
Recruitment Status : Terminated (Difficulty recruiting)
First Posted : August 24, 2015
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Nicole Bender, University of Southern California

Tracking Information
First Submitted Date  ICMJE August 19, 2015
First Posted Date  ICMJE August 24, 2015
Results First Submitted Date  ICMJE May 7, 2019
Results First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 31, 2019
Study Start Date  ICMJE August 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
Levonorgestrel Area Under the Curve [ Time Frame: 24 days ]
Levonorgestrel AUC from 0 to 72 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02531321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
  • Ethinyl Estradiol Area Under the Curve [ Time Frame: 24 days ]
    Ethinyl estradiol area under the curve from 0 to 72 hours
  • Serum Progesterone Level >3ng/dL Reflecting Ovulation [ Time Frame: 21 days ]
    Progesterone >3ng/dL at any time during pill use
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics
Official Title  ICMJE Effects of Protease Inhibitor Use on Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics in HIV-positive Women
Brief Summary

The project is a two-arm prospective cohort and pharmacokinetic study comparing levonorgestrel and ethinyl estradiol pharmacokinetics in HIV-positive women taking antiretroviral regimens that include ritonavir to those in women who take regimens known not to interact with combined oral contraceptives. In addition, the prevalence of ovulation will be measured in each group. Participants will take a combined oral contraceptive containing levonorgestrel and ethinyl estradiol for 21 days, during which they will undergo twice-weekly serum progesterones. On the final day, they will complete a pharmacokinetic study. The investigators hypothesize that levonorgestrel levels, as measured by area-under-the-curve from 0 to 72 hours, will be increased in women on ritonavir, while ethinyl estradiol levels will be decreased and ovulation, defined by a serum progesterone of at least 3 ng/mL, will be unchanged.

This study will be the first to evaluate the effects of ritonavir on the pharmacokinetics of a combined oral contraceptive containing the progestin levonorgestrel. In addition, no previous studies have rigorously assessed ovulation in women taking protease inhibitors and combined oral contraceptives. As a result, this study will provide new information correlating pharmacokinetic changes with effects on ovulation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Contraception
  • HIV
Intervention  ICMJE Drug: Levonorgestrel and Ethinyl Estradiol
All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives.
Study Arms  ICMJE
  • Experimental: Ritonavir
    Participants taking antiretroviral regimens including ritonavir-boosted protease inhibitors will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.
    Intervention: Drug: Levonorgestrel and Ethinyl Estradiol
  • Active Comparator: Control
    Participants taking antiretroviral regimens known not to interact with oral contraceptives will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.
    Intervention: Drug: Levonorgestrel and Ethinyl Estradiol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 30, 2017)
17
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2015)
30
Actual Study Completion Date  ICMJE November 1, 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV positive
  • Female
  • Age 18-45
  • Using any of the following medication regimens: no ARV medication, entry inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), integrase inhibitors, and CCR5 agonists. Acceptable NRTI combinations include zidovudine (ZDV), lamivudine (3TC), emtricitabine (FTC), didanosine (ddl), stavudine (d4T), abacavir (ABC), and tenofovir disoproxil fumarate (TDF)
  • Ovulatory (mid-luteal progesterone >3ng/dL)
  • Not planning to conceive during the study period
  • Willing to abstain from grapefruit products
  • If taking ritonavir, willing to use alternate non-hormonal contraception
  • BMI < or = 40
  • Able to consent in English or Spanish
  • No change in medication regimen for at least 21 days prior to study entry and no planned change during the study period
  • CD4 > or =200, and/or not considered profoundly immuncompromised by primary HIV provider

Exclusion Criteria:

  • Using on the combination of ZDV at d4T
  • Platelets <50,000
  • AST or ALT > twice upper limit of normal
  • Bilirubin > twice upper limit of normal
  • Use of other CYP3A4 inducing or inhibiting medications
  • Pregnant or breastfeeding in last 30 days
  • Use of DepoProvera in last 180 days
  • Use of any other hormonal contraception in last 30 days
  • Undiagnosed vaginal bleeding or invasive cancer of the reproductive tract

    ->50% change in tobacco use in the last month

  • Initiation or titration of methadone therapy in the last month
  • Uncontrolled thyroid disease
  • Contraindication to estrogen use
  • Inability to comply with study protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02531321
Other Study ID Numbers  ICMJE HS-15-00112
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nicole Bender, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Southern California
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP