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Sponsored by: |
Population Council |
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Information provided by: | Population Council |
ClinicalTrials.gov Identifier: | NCT00796133 |
This is a Phase 2, dose-finding, cross-over study for the purposes of evaluating the effect of a NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women.
Condition | Intervention | Phase |
---|---|---|
Ovulation |
Drug: NES/E2 gel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Dose-Finding, Cross-Over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Delivery on Ovulation Suppression in Normal Ovulating Women |
Estimated Enrollment: | 18 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
0.5 ml of NES/E2 equaling 0.45 g and contains 1.5 mg NES/0.5 mg E2
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Drug: NES/E2 gel
Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles. The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES. Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively. The doses of Estradiol will also be tailored to the 3 formulations.
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2: Active Comparator
1.0 ml of NES/E2 gel equaling 0.9 g and contains 3.0 mg NES/1.0 mg E2
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Drug: NES/E2 gel
Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles. The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES. Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively. The doses of Estradiol will also be tailored to the 3 formulations.
|
3: Active Comparator
1.5 ml of NES/E2 gel equaling 4.5 mg NES/1.5 mg E2
|
Drug: NES/E2 gel
Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles. The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES. Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively. The doses of Estradiol will also be tailored to the 3 formulations.
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Regine Sitruk-Ware | 212-327-7045 | rsitrukware@popcouncil.org |
Contact: Ruth Merkatz | 212-327-8647 | rmerkatz@popcouncil.org |
United States, California | |
Women's and Children's Hospital; LA County/USC Medical Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Daniel Mishell, MD 323-226-3416 Mishell@hsc.usc.edu | |
Contact: DeShawn Taylor, MD 323-226-3416 deshawnt@usc.edu | |
Principal Investigator: Daniel Mishell, MD | |
Sub-Investigator: DeShawn Taylor, MD | |
Chile | |
Instituto Chileno de Medicina Reproductiva | Recruiting |
Santiago, Chile | |
Contact: Cristian Jesam, MD 011-56 2 632 4644 cjesam@icmer.org | |
Principal Investigator: Cristian Jesam, MD | |
Dominican Republic | |
PROFAMILIA | Recruiting |
Santo Domingo, Dominican Republic | |
Contact: Vivian Brache, Lic. 809-681-8357 biomedica@codetel.net.do | |
Principal Investigator: Vivian Brache, Lic. |
Responsible Party: | Population Council ( Regine Sitruk-Ware, Study Coordinator ) |
Study ID Numbers: | Population Council #427 |
Study First Received: | November 21, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00796133 |
Health Authority: | United States: Food and Drug Administration; Chile: Instituto de Salud Publica de Chile; Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS) |
NES/E2 transdermal gel delivery contraception ovulation bleeding patterns |
Signs and Symptoms Estradiol 3-benzoate Estradiol valerate Estradiol 17 beta-cypionate |
Polyestradiol phosphate Hemorrhage Estradiol |