Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch Compared to Oral Treatment With Clomiphene or Placebo in Infertile Females
Public ClinicalTrials.gov record NCT00796289. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch (Lutrepatch) Compared to Oral Treatment With Clomiphene Citrate or Placebo in Anovulatory or Oligoovulatory Infertile Females
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to determine the safety and efficacy of pulsatile GnRH delivered from a iontophoretic patch (Lutrepatch) for induction of ovulation in women with anovulatory/ oligoovulatory infertility, compared to placebo and to a reference treatment with clomiphene citrate.
Study identification
- NCT ID
- NCT00796289
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Interventions
- GnRH iontophoretic transdermal Lutrepatch Drug
- clomiphene citrate Drug
- placebo clomiphene citrate Drug
- placebo GnRH patch Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 38 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2009 (Type not available)
- Primary completion
- Dec 2009 (Actual)
- Completion
- Jan 2010 (Actual)
- Last update posted
- Sep 9, 2015
2009 – 2010
United States locations
- U.S. sites
- 35
- U.S. states
- 22
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Watching Over Mothers and Babies Foundation | Tucson | Arizona | 85712 | — |
| NEA Women's Clinic | Jonesboro | Arkansas | 72401 | — |
| San Diego Fertility Center | San Diego | California | 92130 | — |
| Compass Clinical Research | San Ramon | California | 94583 | — |
| North Coast Women's Care Medical Group | Vista | California | 92083 | — |
| Huntington Reproductive Center | Westlake Village | California | 91361 | — |
| Florida Fertility Institute | Clearwater | Florida | 33759 | — |
| All Women's Healthcare of Wesy Broward, Inc. | Plantation | Florida | 33324 | — |
| Atlanta Center for Reproductive Medicine | Atlanta | Georgia | 30328 | — |
| Georgia Reproductive Specialists | Atlanta | Georgia | 30342 | — |
| Women's Health Practice | Champaign | Illinois | 61820 | — |
| University of Kentucky | Lexington | Kentucky | 40536-0293 | — |
| A Woman's Center for Reproductive Medicine | Baton Rouge | Louisiana | 70815 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Shady Grove Fertility Center | Rockville | Maryland | 20850 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Hutzel Women's Health Specialists | Detroit | Michigan | 48201 | — |
| CAREM Canadian American Reproductive Medicine | Hamtramck | Michigan | 48212 | — |
| Women's Clinic of Lincoln, P.C. | Lincoln | Nebraska | 68510 | — |
| Fertility Center of Las Vegas | Las Vegas | Nevada | 89117 | — |
| The Medical Group of Northern Nevada | Reno | Nevada | 89502 | — |
| Women's Health Research Center LLC | Lawrenceville | New Jersey | 08648 | — |
| Columbia University | New York | New York | 10032 | — |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| Lyndhurst Gynecologic Associates | Winston-Salem | North Carolina | 27103 | — |
| Institute for Reproductive Health | Cincinnati | Ohio | 45209 | — |
| Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research | Cincinnati | Ohio | 45267-0457 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Clinical Trials of America Inc | Eugene | Oregon | 97401 | — |
| Center for Health and Healing | Portland | Oregon | 97239 | — |
| Greenville Hospital System | Greenville | South Carolina | 29605 | — |
| Research Memphis Associates, LLC | Memphis | Tennessee | 38119 | — |
| Center for Assisted Reproduction | Bedford | Texas | 76022 | — |
| The Methodist Hospital | Houston | Texas | 77030 | — |
| Center of Reproductive Medicine | Webster | Texas | 77598 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00796289, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2015 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00796289 live on ClinicalTrials.gov.