Status:
COMPLETED
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
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
FEMALE
18-38 years
Phase:
PHASE2
Brief Summary
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/ ol...
Eligibility Criteria
Inclusion
- Females between the ages of 18 and 38 years
- Desire to become pregnant
- Infertile due to ovulatory dysfunction as described below:
- Unable to conceive for at least 1 year and
- Anovulatory (defined as 4 or fewer menstrual cycles per year) or Oligo-ovulatory (defined as menstrual cycle frequency \> 45 days)
Exclusion
- Requires donor oocytes or sperm
- Two or more failed (defined as no biochemical pregnancy achieved) gonadotropin fertility treatment cycles - if previous gonadotropin success, no more than two failed subsequent cycles
- Use of insulin-sensitizing drugs (e.g., Metformin) within 1 month prior to progesterone challenge
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00796289
Start Date
February 1 2009
End Date
January 1 2010
Last Update
September 9 2015
Active Locations (35)
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1
Watching Over Mothers and Babies Foundation
Tucson, Arizona, United States, 85712
2
NEA Women's Clinic
Jonesboro, Arkansas, United States, 72401
3
San Diego Fertility Center
San Diego, California, United States, 92130
4
Compass Clinical Research
San Ramon, California, United States, 94583