Trial Outcomes & Findings for Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics (NCT NCT02531321)

NCT ID: NCT02531321

Last Updated: 2019-05-31

Results Overview

Levonorgestrel AUC from 0 to 72 hours

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: 24 days
• Results posted on: 2019-05-31

Participant Flow

Participant milestones

Measure	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. 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.	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. 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 Study STARTED	7	10
Overall Study COMPLETED	5	10
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics

Baseline characteristics by cohort

Measure	Ritonavir n=5 Participants 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.	Control n=10 Participants 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 n=15 Participants Total of all reporting groups
Age, Continuous	38 years n=5 Participants	34.5 years n=7 Participants	35 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	10 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 days

Levonorgestrel AUC from 0 to 72 hours

Outcome measures

Measure	Ritonavir n=5 Participants 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.	Control n=10 Participants 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.
Levonorgestrel Area Under the Curve	321 ng/mL*h Standard Deviation 61	243 ng/mL*h Standard Deviation 83

SECONDARY outcome

Timeframe: 24 days

Ethinyl estradiol area under the curve from 0 to 72 hours

Outcome measures

Measure	Ritonavir n=5 Participants 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.	Control n=10 Participants 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.
Ethinyl Estradiol Area Under the Curve	3867 ng/mL*h Standard Deviation 976	3270 ng/mL*h Standard Deviation 744

SECONDARY outcome

Timeframe: 21 days

Progesterone >3ng/dL at any time during pill use

Outcome measures

Outcome data not reported

Adverse Events

Ritonavir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nicole Bender

University of Southern California

Phone: 3234093416

Email: nicole.bender@med.usc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place