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Trial record 69 of 404 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

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.


Condition or disease Intervention/treatment Phase
Contraception HIV Drug: Levonorgestrel and Ethinyl Estradiol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Protease Inhibitor Use on Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics in HIV-positive Women
Study Start Date : August 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 1, 2016


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. Levonorgestrel Area Under the Curve [ Time Frame: 24 days ]
    Levonorgestrel AUC from 0 to 72 hours


Secondary Outcome Measures :
  1. Ethinyl Estradiol Area Under the Curve [ Time Frame: 24 days ]
    Ethinyl estradiol area under the curve from 0 to 72 hours

  2. Serum Progesterone Level >3ng/dL Reflecting Ovulation [ Time Frame: 21 days ]
    Progesterone >3ng/dL at any time during pill use



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531321


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California

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Responsible Party: Nicole Bender, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02531321     History of Changes
Other Study ID Numbers: HS-15-00112
First Posted: August 24, 2015    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Ritonavir
HIV Protease Inhibitors
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Protease Inhibitors
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic