FertilityPhase 3NCT00296478
Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF)
A Phase 3 study testing Endometrin and Crinone in people with Fertility, run by Ferring Pharmaceuticals.
Trial summary
This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Endometrin and Crinone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,211 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Jul 2006
- Phase
- Phase 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pre-menopausal females between the ages of 18 and 42 years Non-smokers. For females who are past smokers, they must have stopped tobacco usage for at least 3 months prior to baseline visit.
- Early follicular phase (day 2-4) FSH (follicle stimulating hormone) less than or equal to 15 IU/L and Estradiol within normal limits
- LH (luteinizing hormone), PRL (prolactin), T (testosterone), DHEA-S (dehydroepiandrosterone sulfate) and TSH (thyroid-stimulating hormone), within the normal limits for the clinical laboratory, or considered not clinically significant by the investigator within 6 months prior to screening.
- Negative serum hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and rapid plasma reagin tests within 3 months prior to screening
- Seropositive for rubella and varicella and ABO grouping and Rho (D) typing prior to screening
- Documented history of infertility (eg, unable to conceive for at least one year or for 6 months for women ≥38 years of age or bilateral tubal occlusion or absence).
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- Male partner with recent (within 6 months prior to screening) semen analysis showing normalcy adequate for IVF by standard WHO and/or Kruger criteria. Donor sperm may be used, if indicated, provided that it meets standard WHO criteria.
- Normal Transvaginal ultrasound at screening (or within 14 days of screening) with presence of both at least ovaries without evidence of clinically significant abnormality consistent with findings adequate for ART with respect to uterus and adnexa (no hydrosalpinx or clinically relevant uterine fibroids).
- At least one cycle with no fertility medication prior to screening.
- Hysterosalpingography, hysteroscopy, or sonohysterogram documenting a normal uterine cavity.
- Negative pregnancy test on the day of pituitary down regulation (prior to administration of GnRH agonist).
- Signed informed consent.
Who cannot join
- Requires Donor oocyte or embryo recipient; gestational or surrogate carrier
- Undergoing blastomer biopsy and other experimental ART procedures
- Inadequate number of oocytes defined as fewer than 3 oocytes retrieved in the study cycle
- Presence of any clinically relevant systemic disease (eg, insulin-dependent diabetes mellitus).
- 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.
- Subjects with a body mass index (BMI) of greater than 34 at time of Screening.
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- Previous IVF or ART failure due to related to either a sperm/fertilization problem which resulted in unsuccessful fertilization or an ART with a poor response to gonadotropins. Poor response is defined as development of less than 2 mature follicles or history of 2 previous cycle cancellations prior to oocyte retrieval due to poor response.
- Presence of abnormal uterine bleeding of undetermined origin.
- Current or recent substance abuse, including alcohol and tobacco. (Note: Patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed).
- 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.
- For male partner, obvious leukospermia (> 2 million WBC/mL) or signs of infection in semen sample within past 2 months of pituitary down regulation; if either of these conditions exists, male should be treated with antibiotics and retested prior to his partner's pituitary down regulation.
- 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.
- Use of any of the following medications during the pretreatment and treatment phase: hormonal drug products (use of oral contraceptives during down regulation is allowed), progesterone creams, hydrocortisone and other steroid drug products, and fertility modifiers such as insulin sensitizers.
- History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
About this study
This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
Read the detailed description
This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
- Conditions
- Fertility
- Being tested
- Endometrin, Crinone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndometrinDrug
Endometrin 100mg BID x 10weeks
EndometrinDrug
Endometrin 100mg TID x 10weeks
CrinoneDrug
Crinone QD x 10weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Endometrin 100mg BID Receives: Drug: Endometrin |
| 2 | Experimental | Endometrin 100mg TID Receives: Drug: Endometrin |
| 3 | Active comparator | Crinone Receives: Drug: Crinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy.
Measured: 6 weeks
Secondary outcomes (1)
Biochemical pregnancy, clinical pregnancy, pregnancy outcome.
Measured: 1 year
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 startJul 2005
- Primary completionApr 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,211 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
- NCT00296478
- Sponsor's protocol ID
- FE999913 2004-02
- Status last verified
- May 2011
- First submitted
- 23 Feb 2006
- Last updated
- 19 May 2011
- Results posted
- No
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
- Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT00296478
- Acronym / sponsor ID
- FE999913 2004-02
- Conditions
- Fertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,211 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Jul 2006 (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 multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
Detailed description
This multicenter, randomized, open-label study will be performed in approximately 990 healthy females undergoing IVF. Each study center will follow their study center standard practice for IVF unless otherwise noted in this protocol. The study centers will be provided with the medications for down regulation, stimulation and ovulation induction. The subjects will be randomized to study medication on the day of oocyte retrieval or the day following and will continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be required to return to the clinic several times during the course of the 10 week treatment period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EndometrinEndometrin 100mg BID |
| 2 | Experimental | Drug: EndometrinEndometrin 100mg TID |
| 3 | Active comparator | Drug: CrinoneCrinone |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Pre-menopausal females between the ages of 18 and 42 years Non-smokers. For females who are past smokers, they must have stopped tobacco usage for at least 3 months prior to baseline visit.
- Early follicular phase (day 2-4) FSH (follicle stimulating hormone) less than or equal to 15 IU/L and Estradiol within normal limits
- LH (luteinizing hormone), PRL (prolactin), T (testosterone), DHEA-S (dehydroepiandrosterone sulfate) and TSH (thyroid-stimulating hormone), within the normal limits for the clinical laboratory, or considered not clinically significant by the investigator within 6 months prior to screening.
- Negative serum hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and rapid plasma reagin tests within 3 months prior to screening
- Seropositive for rubella and varicella and ABO grouping and Rho (D) typing prior to screening
Key exclusion criteria (17 listed)
- Requires Donor oocyte or embryo recipient; gestational or surrogate carrier
- Undergoing blastomer biopsy and other experimental ART procedures
- Inadequate number of oocytes defined as fewer than 3 oocytes retrieved in the study cycle
- Presence of any clinically relevant systemic disease (eg, insulin-dependent diabetes mellitus).
- 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 |
|---|---|---|
| EndometrinEndometrin 100mg BID x 10weeks | Drug | 1 |
| EndometrinEndometrin 100mg TID x 10weeks | Drug | 2 |
| CrinoneCrinone QD x 10weeks | Drug | 3 |
Primary outcome
Ongoing pregnancy.
Time frame: 6 weeks
1 secondary outcome
Biochemical pregnancy, clinical pregnancy, pregnancy outcome.
Time frame: 1 year
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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endometrin and Crinone in people with Fertility, run by Ferring Pharmaceuticals.
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 12 inclusion and 17 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 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?
Ongoing pregnancy. (time frame: 6 weeks). 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.