Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT02697851
Status:
TERMINATED
Last Update Posted:
2018-01-02
First Post:
2016-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Effect of Evotaz/Microgynon Co-administration
Sponsor:
St Stephens Aids Trust
Organization:
Study Overview
Official Title:
The Effect of Atazanavir/Cobicistat on the Pharmacokinetics of an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon 30®) in Healthy Women
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient enrolment and "business reasons"
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There will be two study arms, who will take the medications in different orders:
GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56.
GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56.
Detailed Description:
Protocol Number: SSAT069
EudraCT Number: 2015-004799-30
Name of Investigational Product: Microgynon 30®; Evotaz®
Name of active ingredients: Ethinylestradiol, levonorgestrel; atazanavir, cobicistat
Study title: The effect of atazanavir/cobicistat on the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel (Microgynon 30®) in healthy women
Phase of study: Phase I
Objectives: The objectives of this study are:
Primary
-To assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers
Secondary
* To assess the safety and tolerability of ethinylestradiol/levonorgestrel and atazanavir/cobicistat when co-administered to HIV negative female healthy volunteers
* To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
Study design: 57 days (excluding screening and follow up), open label, cross-over, pharmacokinetic study
Indication: Not applicable
Methodology: Measurements of steady state pharmacokinetic profiles of plasma ethinylestradiol/levonorgestrel and atazanavir/cobicistat
Planned sample size: Up to 30 female healthy volunteers will be enrolled at baseline in order to achieve 18 completing the study
Summary of eligibility criteria: Healthy female participants as determined by medical history, physical examination, 12-lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. Women of childbearing potential must not be nursing or pregnant. Women of childbearing potential must have a negative pregnancy test at screening.
Number of study centres: One
Duration of treatment: 57 days (excluding screening and follow up visits)
Dose and route of administration: All participants will be administered Microgynon 30® (ethinylestradiol/levonorgestrel 30 micrograms/150 micrograms) and Evotaz® (atazanavir 300 mg/cobicistat 150 mg) as follows:
GROUP 1:
Microgynon 30® for 21 days Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days Followed by Evotaz® for 14 days
GROUP 2:
Evotaz® for 14 days followed by 7 days wash-out Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack)
Criteria for evaluation: Pharmacokinetic parameters of ethinylestradiol/levonorgestrel and atazanavir/cobicistat will be evaluated on blood drawn on day 14, 35 and 56 at 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24 hours post dose
Safety and tolerability of medications will also be assessed by questions, physical examination and laboratory parameters. These will be performed at regular intervals during the drug study.
Primary Endpoint: Steady state plasma concentrations of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers
Secondary End point: Safety and tolerability of the studied drugs during co-administration
Relationship between genetic polymorphisms and exposure to the studied drugs
EudraCT Number: 2015-004799-30
Name of Investigational Product: Microgynon 30®; Evotaz®
Name of active ingredients: Ethinylestradiol, levonorgestrel; atazanavir, cobicistat
Study title: The effect of atazanavir/cobicistat on the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel (Microgynon 30®) in healthy women
Phase of study: Phase I
Objectives: The objectives of this study are:
Primary
-To assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers
Secondary
* To assess the safety and tolerability of ethinylestradiol/levonorgestrel and atazanavir/cobicistat when co-administered to HIV negative female healthy volunteers
* To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
Study design: 57 days (excluding screening and follow up), open label, cross-over, pharmacokinetic study
Indication: Not applicable
Methodology: Measurements of steady state pharmacokinetic profiles of plasma ethinylestradiol/levonorgestrel and atazanavir/cobicistat
Planned sample size: Up to 30 female healthy volunteers will be enrolled at baseline in order to achieve 18 completing the study
Summary of eligibility criteria: Healthy female participants as determined by medical history, physical examination, 12-lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. Women of childbearing potential must not be nursing or pregnant. Women of childbearing potential must have a negative pregnancy test at screening.
Number of study centres: One
Duration of treatment: 57 days (excluding screening and follow up visits)
Dose and route of administration: All participants will be administered Microgynon 30® (ethinylestradiol/levonorgestrel 30 micrograms/150 micrograms) and Evotaz® (atazanavir 300 mg/cobicistat 150 mg) as follows:
GROUP 1:
Microgynon 30® for 21 days Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days Followed by Evotaz® for 14 days
GROUP 2:
Evotaz® for 14 days followed by 7 days wash-out Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack)
Criteria for evaluation: Pharmacokinetic parameters of ethinylestradiol/levonorgestrel and atazanavir/cobicistat will be evaluated on blood drawn on day 14, 35 and 56 at 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24 hours post dose
Safety and tolerability of medications will also be assessed by questions, physical examination and laboratory parameters. These will be performed at regular intervals during the drug study.
Primary Endpoint: Steady state plasma concentrations of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers
Secondary End point: Safety and tolerability of the studied drugs during co-administration
Relationship between genetic polymorphisms and exposure to the studied drugs
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: