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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
350
10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'high target' study dose, which is estimated to be 800 picograms/ml
10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day(every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'medium target' study dose, which is estimated to be 400-600 picograms/ml
10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'low target' study dose, which is estimated to be 200 picograms/ml
Ovulation rate
Time frame: 30 days
Pregnancy rate
Time frame: 30 days
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: 30 days
Incidence of skin irritation
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oral, 50 mg daily for 5 days
oral, taken for 5 days
Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.
Watching Over Mothers and Babies Foundation
Tucson, Arizona, United States
NEA Women's Clinic
Jonesboro, Arkansas, United States
San Diego Fertility Center
San Diego, California, United States
Compass Clinical Research
San Ramon, California, United States
North Coast Women's Care Medical Group
Vista, California, United States
Huntington Reproductive Center
Westlake Village, California, United States
Florida Fertility Institute
Clearwater, Florida, United States
All Women's Healthcare of Wesy Broward, Inc.
Plantation, Florida, United States
Atlanta Center for Reproductive Medicine
Atlanta, Georgia, United States
Georgia Reproductive Specialists
Atlanta, Georgia, United States
...and 25 more locations