Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH High Target Delivery | Experimental | 10 mg GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days |
|
| GnRH Medium Target Delivery | Experimental | 10 mg GnRH iontophoretic transdermal Lutrepatch with a medium target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days |
|
| GnRH Low Target Delivery | Experimental | 10 mg GnRH iontophoretic transdermal Lutrepatch with a low target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days |
|
| Clomiphene Citrate | Active Comparator | Placebo GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile current (every 90 minutes) for 21 days and oral 50 mg clomiphene citrate for 5 days |
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH iontophoretic transdermal Lutrepatch | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ovulation rate | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | 30 days | |
| Incidence of Ovarian Hyperstimulation Syndrome (OHSS) | 30 days | |
| Incidence of skin irritation |
Not provided
Inclusion Criteria:
Females between the ages of 18 and 38 years
Desire to become pregnant
Infertile due to ovulatory dysfunction as described below:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Watching Over Mothers and Babies Foundation | Tucson | Arizona | 85712 | United States | ||
| NEA Women's Clinic |
Not provided
Not provided
Not provided
Not provided
Not provided
Placebo GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile current (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days |
|
|
|
| GnRH iontophoretic transdermal Lutrepatch | Drug | 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 |
|
|
| GnRH iontophoretic transdermal Lutrepatch | Drug | 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 |
|
|
| clomiphene citrate | Drug | Oral, 50 mg daily for 5 days |
|
|
| placebo clomiphene citrate | Drug | oral, taken for 5 days |
|
| placebo GnRH patch | Drug | Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours. |
|
| 30 days |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| San Diego Fertility Center | San Diego | California | 92130 | United States |
| Compass Clinical Research | San Ramon | California | 94583 | United States |
| North Coast Women's Care Medical Group | Vista | California | 92083 | United States |
| Huntington Reproductive Center | Westlake Village | California | 91361 | United States |
| Florida Fertility Institute | Clearwater | Florida | 33759 | United States |
| All Women's Healthcare of Wesy Broward, Inc. | Plantation | Florida | 33324 | United States |
| Atlanta Center for Reproductive Medicine | Atlanta | Georgia | 30328 | United States |
| Georgia Reproductive Specialists | Atlanta | Georgia | 30342 | United States |
| Women's Health Practice | Champaign | Illinois | 61820 | United States |
| University of Kentucky | Lexington | Kentucky | 40536-0293 | United States |
| A Woman's Center for Reproductive Medicine | Baton Rouge | Louisiana | 70815 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Shady Grove Fertility Center | Rockville | Maryland | 20850 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Hutzel Women's Health Specialists | Detroit | Michigan | 48201 | United States |
| CAREM Canadian American Reproductive Medicine | Hamtramck | Michigan | 48212 | United States |
| Women's Clinic of Lincoln, P.C. | Lincoln | Nebraska | 68510 | United States |
| Fertility Center of Las Vegas | Las Vegas | Nevada | 89117 | United States |
| The Medical Group of Northern Nevada | Reno | Nevada | 89502 | United States |
| Women's Health Research Center LLC | Lawrenceville | New Jersey | 08648 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| Lyndhurst Gynecologic Associates | Winston-Salem | North Carolina | 27103 | United States |
| Institute for Reproductive Health | Cincinnati | Ohio | 45209 | United States |
| Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research | Cincinnati | Ohio | 45267-0457 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Clinical Trials of America Inc | Eugene | Oregon | 97401 | United States |
| Center for Health and Healing | Portland | Oregon | 97239 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Research Memphis Associates, LLC | Memphis | Tennessee | 38119 | United States |
| Center for Assisted Reproduction | Bedford | Texas | 76022 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Center of Reproductive Medicine | Webster | Texas | 77598 | United States |
| ID | Term |
|---|---|
| D007246 | Infertility |
| D000858 | Anovulation |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided