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Trial record 70 of 407 for:    LEVONORGESTREL

Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Contraception
HIV
Intervention Drug: Levonorgestrel and Ethinyl Estradiol
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ritonavir Control
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 7 10
Completed 5 10
Not Completed 2 0
Arm/Group Title Ritonavir Control Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 5 10 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 10 participants 15 participants
38
(29 to 41)
34.5
(30 to 42)
35
(29 to 42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 10 participants 15 participants
Female
5
 100.0%
10
 100.0%
15
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 10 participants 15 participants
5 10 15
1.Primary Outcome
Title Levonorgestrel Area Under the Curve
Hide Description Levonorgestrel AUC from 0 to 72 hours
Time Frame 24 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ritonavir Control
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 5 10
Mean (Standard Deviation)
Unit of Measure: ng/mL*h
321  (61) 243  (83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ritonavir, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments Unpaired t test with Welch’s correction
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Ethinyl Estradiol Area Under the Curve
Hide Description Ethinyl estradiol area under the curve from 0 to 72 hours
Time Frame 24 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ritonavir Control
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 5 10
Mean (Standard Deviation)
Unit of Measure: ng/mL*h
3867  (976) 3270  (744)
3.Secondary Outcome
Title Serum Progesterone Level >3ng/dL Reflecting Ovulation
Hide Description Progesterone >3ng/dL at any time during pill use
Time Frame 21 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ritonavir Control
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Ritonavir Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ritonavir Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ritonavir Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nicole Bender
Organization: University of Southern California
Phone: 3234093416
EMail: nicole.bender@med.usc.edu
Layout table for additonal information
Responsible Party: Nicole Bender, University of Southern California
ClinicalTrials.gov Identifier: NCT02531321     History of Changes
Other Study ID Numbers: HS-15-00112
First Submitted: August 19, 2015
First Posted: August 24, 2015
Results First Submitted: May 7, 2019
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019