The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception (NET)

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Jessica Maria Atrio, University of Southern California
ClinicalTrials.gov Identifier:
NCT01667978
First received: August 15, 2012
Last updated: August 19, 2015
Last verified: August 2015
Results First Received: May 27, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pregnancy
HIV
AIDS
Intervention: Drug: Norethindrone acetate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)


Participant Flow:   Overall Study
    Protease Inhibitor     Control  
STARTED     18     17  
COMPLETED     16     17  
NOT COMPLETED     2     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Protease Inhibitor

Study group with PI: atazanavir ritonavir

Norethindrone acetate

Control

o PI therapy, control group

Norethindrone acetate

Total Total of all reporting groups

Baseline Measures
    Protease Inhibitor     Control     Total  
Number of Participants  
[units: participants]
  18     17     35  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     17     35  
>=65 years     0     0     0  
Age  
[units: years]
Median (Inter-Quartile Range)
  39.9   (35.9 to 42.3)     38   (33.4 to 41.3)     39   (34 to 41)  
Gender  
[units: participants]
     
Female     18     17     35  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     18     17     35  



  Outcome Measures

1.  Primary:   AUC Norethindrone   [ Time Frame: following 21 days of continuous ingestion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Jessica Atrio
Organization: Montefiore
phone: 718 405 82 60
e-mail: jatrio@montefiore.org


No publications provided by University of Southern California

Publications automatically indexed to this study:

Responsible Party: Jessica Maria Atrio, University of Southern California
ClinicalTrials.gov Identifier: NCT01667978     History of Changes
Other Study ID Numbers: HS-12-00005
Study First Received: August 15, 2012
Results First Received: May 27, 2015
Last Updated: August 19, 2015
Health Authority: United States: Institutional Review Board