InFertilityPhase 2/3NCT00296465
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH
A Phase 2/3 study testing Pulsatile gonadotropin-releasing hormone (GnRH) and Clomiphene Citrate in people with InFertility, run by Ferring Pharmaceuticals at 1 site in United States.
Trial summary
This study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- InFertility
- What is being tested?
- Pulsatile gonadotropin-releasing hormone (GnRH) and Clomiphene Citrate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Nov 2005
- Phase
- Phase 2/3
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females between the ages of 18 (or 19 in the State of Alabama) and 40 years.
- Infertile due to ovulatory dysfunction as described below:
- Positive progesterone withdrawal test following the screening visit.
- TSH (thyroid-stimulating hormone) levels within normal limits for the clinical laboratory or considered not clinically significant (eg, secondary to exogenous thyroid medication) by the investigator
- Normal insulin sensitivity assessed as ratio of fasting blood glucose to fasting insulin > 4.5 at Screening
- Male partner with recent (within 6 months prior to screening) semen analysis showing normalcy according to the local laboratory normal criteria. If screening semen analysis is borderline, the couple will be accepted into the study only if a second sample obtained prior to screening is adequate.
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- Presence of both ovaries, without evidence of clinically significant abnormality, as detected by transvaginal ultrasound
- Normal transvaginal ultrasound with respect to uterus and adnexa (eg, no hydrosalpinx)
- Hysterosalpingography or hysteroscopy or sonohysterogram documenting a uterine cavity consistent with expected normal function and patency of the fallopian tubes within the previous 3 years prior to screening (within 1 year prior to screening there should be no pelvic infection, endometriosis or pelvic surgery).
- Negative serum pregnancy test (qualitative) prior to the progesterone test
- Desire to become pregnant
Who cannot join
- Requires donor oocytes or sperm
- Previous and current use of infertility modifiers, including insulin-sensitizing drugs
- Primary amenorrhea/hypogonadotropic hypogonadism (eg, isolated gonadotropin deficiency or evidence of primary/premature ovarian failure)
- Presence of any clinically relevant systemic disease (eg, diabetes mellitus, pituitary tumor, anorexia nervosa).
- Surgical or medical condition which in the judgment of the Investigator or Sponsor may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
- Any pregnancy within last 3 months prior to Screening.
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- Patients with a body mass index (BMI) >30 at time of Screening
- Total testosterone and DHEA-S >1.5 times the upper limits of normal laboratory range and prolactin > 20 ng/mL
- Presence of abnormal uterine bleeding of undetermined origin.
- Active or prior history of substance abuse
- History of chemotherapy (except for gestational conditions) or radiotherapy
- Currently breast feeding, pregnant or contraindication to pregnancy
- Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests.
- Documented intolerance or allergy to any of the medications used including the study medication
- Participation in any experimental drug study within 60 days prior to Screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Fertility Center and Clinical Research
Metairie, Louisiana, 70002
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Administered Intravenously or Subcutaneously (Via Portable Infusion Pump) Compared to Oral Treatment With Clomiphene Citrate in Anovulatory or Oligoovulatory Infertile Females
This study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility.
Read the detailed description
This multicenter, randomized, double-blind, placebo-controlled study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility. The treatment duration will be approximately 4 weeks with pulsatile GnRH or placebo and 5 days with Clomiphene Citrate or placebo. All subjects will be screened based on inclusion/exclusion criteria, medical/infertility history and general safety assessments. Subjects that complete screening will be dispensed 100 mg of oral progesterone twice a day for 10 days to induce uterine bleeding. On Cycle Day 5 from the start of bleeding the subject will be randomly assigned to 1 of 7 treatment groups. All subjects will be monitored weekly throughout the 4 week treatment period for ovulation and intercourse will be timed. All subjects will be required to return to the study center for a total of 8 visits. In addition, all subjects with a confirmed clinical pregnancy will be monitored until fetal heartbeat is confirmed at approximately 5-6 weeks gestation
- Conditions
- InFertility
- Being tested
- Pulsatile gonadotropin-releasing hormone (GnRH), Clomiphene Citrate, Placebo Pulsatile GnRH, Placebo Clomiphene Citrate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsatile gonadotropin-releasing hormone (GnRH)Drug
Also called Lutrepulse®
Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Clomiphene CitrateDrug
Also called Clomid
Oral clomiphene citrate (over encapsulated) for 5 days
Placebo Pulsatile GnRHDrug
Administered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks
Placebo Clomiphene CitrateDrug
oral placebo clomiphene citrate for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Lutrepulse® 5mcg IV | Experimental | 5.0 mcg Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days Receives: Drug: Pulsatile gonadotropin-releasing hormone (GnRH); Drug: Placebo Clomiphene Citrate |
| Lutrepulse® 10 mcg IV | Experimental | 10.0 mcg Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days Receives: Drug: Pulsatile gonadotropin-releasing hormone (GnRH); Drug: Placebo Clomiphene Citrate |
| Lutrepulse® 20 mcg SC | Experimental | 20.0 mcg Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days Receives: Drug: Pulsatile gonadotropin-releasing hormone (GnRH); Drug: Placebo Clomiphene Citrate |
| Placebo IV | Placebo comparator | Placebo Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days Receives: Drug: Placebo Pulsatile GnRH; Drug: Placebo Clomiphene Citrate |
| Placebo SC | Placebo comparator | Placebo Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days Receives: Drug: Placebo Pulsatile GnRH; Drug: Placebo Clomiphene Citrate |
| Clomiphene Citrate/Placebo IV | Active comparator | Oral clomiphene citrate (over encapsulated) for 5 days and Placebo Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks Receives: Drug: Clomiphene Citrate; Drug: Placebo Pulsatile GnRH |
| Clomiphene Citrate / Placebo SC | Active comparator | Oral clomiphene citrate (over encapsulated) for 5 days and Placebo Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks Receives: Drug: Clomiphene Citrate; Drug: Placebo Pulsatile GnRH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: Day 16
Secondary outcomes (1)
Adverse events, including ovarian hyperstimulation syndrome (OHSS)
Measured: Day 1 to week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startFeb 2005
- Primary completionNov 2005
- Study completionNov 2005
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296465
- Sponsor's protocol ID
- 2004-05
- Status last verified
- May 2011
- First submitted
- 23 Feb 2006
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Administered Intravenously or Subcutaneously (Via Portable Infusion Pump) Compared to Oral Treatment With Clomiphene Citrate in Anovulatory or Oligoovulatory Infertile Females
- ClinicalTrials.gov ID
- NCT00296465
- Acronym / sponsor ID
- 2004-05
- Conditions
- InFertility
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 27 Feb 2006 (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.
This study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility.
Detailed description
This multicenter, randomized, double-blind, placebo-controlled study will be performed in approximately 132 women with anovulatory/oligoovulatory infertility. The treatment duration will be approximately 4 weeks with pulsatile GnRH or placebo and 5 days with Clomiphene Citrate or placebo. All subjects will be screened based on inclusion/exclusion criteria, medical/infertility history and general safety assessments. Subjects that complete screening will be dispensed 100 mg of oral progesterone twice a day for 10 days to induce uterine bleeding. On Cycle Day 5 from the start of bleeding the subject will be randomly assigned to 1 of 7 treatment groups. All subjects will be monitored weekly throughout the 4 week treatment period for ovulation and intercourse will be timed. All subjects will be required to return to the study center for a total of 8 visits. In addition, all subjects with a confirmed clinical pregnancy will be monitored until fetal heartbeat is confirmed at approximately 5-6 weeks gestation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Lutrepulse® 5mcg IV | Experimental | Drug: Pulsatile gonadotropin-releasing hormone (GnRH), Drug: Placebo Clomiphene Citrate5.0 mcg Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days |
| Lutrepulse® 10 mcg IV | Experimental | Drug: Pulsatile gonadotropin-releasing hormone (GnRH), Drug: Placebo Clomiphene Citrate10.0 mcg Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days |
| Lutrepulse® 20 mcg SC | Experimental | Drug: Pulsatile gonadotropin-releasing hormone (GnRH), Drug: Placebo Clomiphene Citrate20.0 mcg Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days |
| Placebo IV | Placebo comparator | Drug: Placebo Pulsatile GnRH, Drug: Placebo Clomiphene CitratePlacebo Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days |
| Placebo SC | Placebo comparator | Drug: Placebo Pulsatile GnRH, Drug: Placebo Clomiphene CitratePlacebo Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks and oral placebo clomiphene citrate for 5 days |
| Clomiphene Citrate/Placebo IV | Active comparator | Drug: Clomiphene Citrate, Drug: Placebo Pulsatile GnRHOral clomiphene citrate (over encapsulated) for 5 days and Placebo Pulsatile GnRH (Lutrepulse®) administered intravenously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks |
| Clomiphene Citrate / Placebo SC | Active comparator | Drug: Clomiphene Citrate, Drug: Placebo Pulsatile GnRHOral clomiphene citrate (over encapsulated) for 5 days and Placebo Pulsatile GnRH (Lutrepulse®) administered subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Females between the ages of 18 (or 19 in the State of Alabama) and 40 years.
- Infertile due to ovulatory dysfunction as described below:
- Positive progesterone withdrawal test following the screening visit.
- TSH (thyroid-stimulating hormone) levels within normal limits for the clinical laboratory or considered not clinically significant (eg, secondary to exogenous thyroid medication) by the investigator
- Normal insulin sensitivity assessed as ratio of fasting blood glucose to fasting insulin > 4.5 at Screening
Key exclusion criteria (15 listed)
- Requires donor oocytes or sperm
- Previous and current use of infertility modifiers, including insulin-sensitizing drugs
- Primary amenorrhea/hypogonadotropic hypogonadism (eg, isolated gonadotropin deficiency or evidence of primary/premature ovarian failure)
- Presence of any clinically relevant systemic disease (eg, diabetes mellitus, pituitary tumor, anorexia nervosa).
- Surgical or medical condition which in the judgment of the Investigator or Sponsor may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
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 |
|---|---|---|
| Pulsatile gonadotropin-releasing hormone (GnRH)Also: Lutrepulse®Dosages as specified, administered either subcutaneously (SC) or intraveneously (IV) as specified, via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks | Drug | Lutrepulse® 10 mcg IV, Lutrepulse® 20 mcg SC, Lutrepulse® 5mcg IV |
| Clomiphene CitrateAlso: ClomidOral clomiphene citrate (over encapsulated) for 5 days | Drug | Clomiphene Citrate / Placebo SC, Clomiphene Citrate/Placebo IV |
| Placebo Pulsatile GnRHAdministered either intravenously or subcutaneously via portable infusion pump in a pulsatile fashion (every 90 minutes) for 4 weeks | Drug | Clomiphene Citrate / Placebo SC, Clomiphene Citrate/Placebo IV, Placebo IV, Placebo SC |
| Placebo Clomiphene Citrateoral placebo clomiphene citrate for 5 days | Drug | Lutrepulse® 10 mcg IV, Lutrepulse® 20 mcg SC, Lutrepulse® 5mcg IV, Placebo IV, Placebo SC |
Primary outcome
Pregnancy rate
Time frame: Day 16
1 secondary outcome
Adverse events, including ovarian hyperstimulation syndrome (OHSS)
Time frame: Day 1 to week 5
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 19 May 2011.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pulsatile gonadotropin-releasing hormone (GnRH) and Clomiphene Citrate in people with InFertility, run by Ferring Pharmaceuticals at 1 site 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 11 inclusion and 15 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 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pregnancy rate (time frame: Day 16). 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 19 May 2011.