Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)
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ClinicalTrials.gov Identifier: NCT00829114 |
Recruitment Status
:
Completed
First Posted
: January 26, 2009
Last Update Posted
: October 31, 2011
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Sponsor:
FHI 360
Collaborators:
United States Agency for International Development (USAID)
Makerere University
RHRU National Office, University of Witwatersand, Johannesburg
Information provided by (Responsible Party):
FHI 360
Tracking Information | |||||||
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First Submitted Date ICMJE | January 16, 2009 | ||||||
First Posted Date ICMJE | January 26, 2009 | ||||||
Last Update Posted Date | October 31, 2011 | ||||||
Study Start Date ICMJE | March 2009 | ||||||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Ovulation as determined by weekly blood progesterone (P) measurement [ Time Frame: 2 months ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00829114 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs) | ||||||
Official Title ICMJE | Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills | ||||||
Brief Summary | Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 4 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Drug: ETHINYL ESTRADIOL AND LEVOGESTREL
30 MCG OF ETHINYL ESTRADIOL AND 150 MCG LEVOGESTREL |
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Study Arms |
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Publications * | Nanda K, Delany-Moretlwe S, Dubé K, Lendvay A, Kwok C, Molife L, Nakubulwa S, Edward VA, Mpairwe B, Mirembe FM. Nevirapine-based antiretroviral therapy does not reduce oral contraceptive effectiveness. AIDS. 2013 Oct;27 Suppl 1:S17-25. doi: 10.1097/QAD.0000000000000050. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Estimated Enrollment ICMJE |
370 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date | April 2011 | ||||||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Pelvic Inflammatory disease Diagnosis of infertility
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Sex/Gender |
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Ages | 18 Years to 35 Years (Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | South Africa, Uganda | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00829114 | ||||||
Other Study ID Numbers ICMJE | 10079 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | FHI 360 | ||||||
Study Sponsor ICMJE | FHI 360 | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | FHI 360 | ||||||
Verification Date | October 2011 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |