Trial Outcomes & Findings for The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception (NCT NCT01667978)
NCT ID: NCT01667978
Last Updated: 2015-08-20
Results Overview
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 21
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
following 21 days of continuous ingestion
Results posted on
2015-08-20
Participant Flow
Participant milestones
| Measure |
Protease Inhibitor
Study group with PI: atazanavir ritonavir
Norethindrone acetate
16 HIV positive on PI (atazanavir ritonavir 10, darunovir, lopinavir)
|
Control
no PI therapy, control group
Norethindrone acetate
17 controls (4 no ARV)
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception
Baseline characteristics by cohort
| Measure |
Protease Inhibitor
n=18 Participants
Study group with PI: atazanavir ritonavir
Norethindrone acetate
|
Control
n=17 Participants
o PI therapy, control group
Norethindrone acetate
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.9 years
n=5 Participants
|
38 years
n=7 Participants
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 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
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: following 21 days of continuous ingestionPopulation: 2 withdrew because unable to present for study visit and another changed her medication
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 21
Outcome measures
| Measure |
Protease Inhibitor
n=16 Participants
Study group with PI: atazanavir ritonavir
Norethindrone acetate
|
Control
n=17 Participants
o PI therapy, control group
Norethindrone acetate
|
|---|---|---|
|
AUC Norethindrone
|
37.81 ng*h/mL
Interval 19.24 to 81.71
|
25.21 ng*h/mL
Interval 15.89 to 42.5
|
Adverse Events
Protease Inhibitor
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place