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NCT01136759 · ClinicalTrials.gov registry record · Phase 1
Tenofovir Gel in Pregnancy and Lactation
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 232
- Enrollment target
NCT01136759: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01136759 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 232 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (287% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01136759, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 232 participants
- Enrollment target
Study Summary
Tenofovir 1% gel is an investigational vaginal microbicide intended to reduce the risk of transmission of HIV. Pregnant women and mothers who have recently given birth often maintain sexual activity, and research has shown that they may be at greater risk of HIV infection during pregnancy. Microbicides may be able to prevent HIV infection during pregnancy, which would also prevent fetal exposure to HIV. This study will test the safety of using tenofovir 1% gel in healthy, pregnant women and healthy, breastfeeding women.
Primary Outcome
Safety and tolerability in pregnant women are assessed by number of specific Grade 2 or greater adverse events in laboratory abnormalities, genital/pelvic signs/symptoms, or pregnancy complications
Interventions
- DRUG Tenofovir 1% gel
- OTHER Placebo gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01136759 record still lists
NCT01136759 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (287% higher).
The record links to 0 conditions, and to 2 interventions - of which Tenofovir 1% gel is the first listed.
NCT01136759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01136759 about?
NCT01136759 is a clinical study titled "Tenofovir Gel in Pregnancy and Lactation". Tenofovir 1% gel is an investigational vaginal microbicide intended to reduce the risk of transmission of HIV. Pregnant women and mothers who have recently given birth often maintain sexual activity, and research has shown that they may be at greater risk of HIV infection during pregnancy. Microbici...
What is the current status of trial NCT01136759?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 232 participants. The study started on 2011-03. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01136759?
The interventions under investigation include: Tenofovir 1% gel (DRUG), Placebo gel (OTHER).
Who is sponsoring clinical trial NCT01136759?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01136759's enrollment target sits among peer trials
232 216th of 2000 higher than 1,784 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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