InfertilityPhase 2NCT00796289
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
A Phase 2 study testing GnRH iontophoretic transdermal Lutrepatch and clomiphene citrate in people with Infertility, run by Ferring Pharmaceuticals at 35 sites in United States.
Trial 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/ oligoovulatory infertility, compared to placebo and to a reference treatment with clomiphene citrate. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- GnRH iontophoretic transdermal Lutrepatch and clomiphene citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 35 sitesUnited States
- Study dates
- Feb 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Atlanta Center for Reproductive Medicine
Atlanta, Georgia, 30328
Georgia Reproductive Specialists
Atlanta, Georgia, 30342
A Woman's Center for Reproductive Medicine
Baton Rouge, Louisiana, 70815
Center for Assisted Reproduction
Bedford, Texas, 76022
Massachusetts General Hospital
Boston, Massachusetts, 02114
Women's Health Practice
Champaign, Illinois, 61820
Institute for Reproductive Health
Cincinnati, Ohio, 45209
Greater Cincinnati OB/GYN, Inc./Reproductive Medicine Research
Cincinnati, Ohio, 45267-0457
Florida Fertility Institute
Clearwater, Florida, 33759
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Hutzel Women's Health Specialists
Detroit, Michigan, 48201
Clinical Trials of America Inc
Eugene, Oregon, 97401
Greenville Hospital System
Greenville, South Carolina, 29605
CAREM Canadian American Reproductive Medicine
Hamtramck, Michigan, 48212
The Methodist Hospital
Houston, Texas, 77030
NEA Women's Clinic
Jonesboro, Arkansas, 72401
Fertility Center of Las Vegas
Las Vegas, Nevada, 89117
Women's Health Research Center LLC
Lawrenceville, New Jersey, 08648
University of Kentucky
Lexington, Kentucky, 40536-0293
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, 68510
Research Memphis Associates, LLC
Memphis, Tennessee, 38119
Columbia University
New York, New York, 10032
All Women's Healthcare of Wesy Broward, Inc.
Plantation, Florida, 33324
Maine Medical Center
Portland, Maine, 04102
Center for Health and Healing
Portland, Oregon, 97239
The Medical Group of Northern Nevada
Reno, Nevada, 89502
Shady Grove Fertility Center
Rockville, Maryland, 20850
San Diego Fertility Center
San Diego, California, 92130
Compass Clinical Research
San Ramon, California, 94583
Albert Einstein College of Medicine
The Bronx, New York, 10461
Watching Over Mothers and Babies Foundation
Tucson, Arizona, 85712
North Coast Women's Care Medical Group
Vista, California, 92083
Center of Reproductive Medicine
Webster, Texas, 77598
Huntington Reproductive Center
Westlake Village, California, 91361
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103
About this study
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
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.
- Conditions
- Infertility
- Being tested
- GnRH iontophoretic transdermal Lutrepatch, clomiphene citrate, placebo clomiphene citrate, placebo GnRH patch
- Keywords
- anovulatory/oligoovulatory infertility
- Medical subject headings
- Infertility, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH iontophoretic transdermal LutrepatchDrug
Also called Lutrepatch, Gonadotropin-releasing hormone (GnRH)
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
GnRH iontophoretic transdermal LutrepatchDrug
Also called Gonadotropin-releasing hormone (GnRH), Lutrepatch
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 LutrepatchDrug
Also called Gonadotropin-releasing hormone (GnRH), Lutrepatch
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 citrateDrug
Also called various tradenames
Oral, 50 mg daily for 5 days
placebo clomiphene citrateDrug
oral, taken for 5 days
placebo GnRH patchDrug
Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: GnRH iontophoretic transdermal Lutrepatch; Drug: placebo clomiphene citrate |
| 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 Receives: Drug: GnRH iontophoretic transdermal Lutrepatch; Drug: placebo clomiphene citrate |
| 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 Receives: Drug: GnRH iontophoretic transdermal Lutrepatch; Drug: placebo clomiphene citrate |
| 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 Receives: Drug: clomiphene citrate; Drug: placebo GnRH patch |
| Placebo | Placebo comparator | 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 Receives: Drug: placebo clomiphene citrate; Drug: placebo GnRH patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
Measured: 30 days
Secondary outcomes (3)
Pregnancy rate
Measured: 30 days
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Measured: 30 days
Incidence of skin irritation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796289
- Sponsor's protocol ID
- 2008-03
- Status last verified
- Aug 2015
- First submitted
- 20 Nov 2008
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00796289
- Acronym / sponsor ID
- 2008-03
- Conditions
- Infertility
- Keywords
- anovulatory/oligoovulatory infertility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GnRH High Target Delivery | Experimental | Drug: GnRH iontophoretic transdermal Lutrepatch, Drug: placebo clomiphene citrate10 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 | Drug: GnRH iontophoretic transdermal Lutrepatch, Drug: placebo clomiphene citrate10 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 | Drug: GnRH iontophoretic transdermal Lutrepatch, Drug: placebo clomiphene citrate10 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 | Drug: clomiphene citrate, Drug: placebo GnRH patchPlacebo 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 | Placebo comparator | Drug: placebo clomiphene citrate, Drug: placebo GnRH patchPlacebo 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 |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females between the ages of 18 and 38 years
- Desire to become pregnant
- Infertile due to ovulatory dysfunction as described below:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GnRH iontophoretic transdermal LutrepatchAlso: Lutrepatch, Gonadotropin-releasing hormone (GnRH)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 | Drug | GnRH High Target Delivery |
| GnRH iontophoretic transdermal LutrepatchAlso: Gonadotropin-releasing hormone (GnRH), Lutrepatch10 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 | Drug | GnRH Medium Target Delivery |
| GnRH iontophoretic transdermal LutrepatchAlso: Gonadotropin-releasing hormone (GnRH), Lutrepatch10 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 | Drug | GnRH Low Target Delivery |
| clomiphene citrateAlso: various tradenamesOral, 50 mg daily for 5 days | Drug | Clomiphene Citrate |
| placebo clomiphene citrateoral, taken for 5 days | Drug | GnRH High Target Delivery, GnRH Low Target Delivery, GnRH Medium Target Delivery, Placebo |
| placebo GnRH patchPlacebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours. | Drug | Clomiphene Citrate, Placebo |
Primary outcome
Ovulation rate
Time frame: 30 days
3 secondary outcomes
Pregnancy rate
Time frame: 30 days
Incidence of Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: 30 days
Incidence of skin irritation
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GnRH iontophoretic transdermal Lutrepatch and clomiphene citrate in people with Infertility, run by Ferring Pharmaceuticals at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.