InfertilityPhase 3NCT00615251
A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization
A Phase 3 study testing DR-2011 and Crinone 8% in people with Infertility, run by Duramed Research at 29 sites in United States.
Trial summary
This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval. 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
- Infertility
- What is being tested?
- DR-2011 and Crinone 8%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,297 participants
- Where
- 29 sitesUnited States
- Study dates
- Feb 2008to Aug 2009
- 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, aged 18-42 old at time of consent
- At least one cycle without fertility medication prior to screening
- Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility
- Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria)
- Others as indicated by FDA-approved protocol
Who cannot join
- Any contraindication to progesterone therapy
- BMI > 38 kg/m2
- Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others)
- History of more than 1 failed fresh IVF cycles
- More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound)
- Others as indicated by FDA-approved protocol
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Duramed Investigational Site
Alpharetta, Georgia, 30005
Duramed Investigational Site
Atlanta, Georgia, 30342
Duramed Investigational Site
Austin, Texas, 78731
Duramed Investigational Site
Beaumont, Texas, 77706
Duramed Investigational Site
Bedford, Texas, 76022
Duramed Investigational Site
Boise, Idaho, 83702
Duramed Investigational Site
Chicago, Illinois, 60610
Duramed Investigational Site
Cincinnati, Ohio, 45209
Duramed Investigational Site
Clearwater, Florida, 33759
Duramed Investigational Site
Columbia, South Carolina, 29201
Duramed Investigational Site
Dearborn, Michigan, 48126
Duramed Investigational Site
Flint, Michigan, 48503
Duramed Investigational Site
Highland Park, Illinois, 60035
Duramed Investigational Site
Marlton, New Jersey, 08053
Duramed Investigational Site
Morristown, New Jersey, 07960
Duramed Investigational Site
Mt. Pleasant, South Carolina, 29464
Duramed Investigational Site
Myrtle Beach, South Carolina, 29577
Duramed Investigational Site
Norfolk, Virginia, 23507
Duramed Investigational Site
Reno, Nevada, 89511
Duramed Investigational Site
Rochester Hills, Michigan, 48307
Duramed Investigational Site
Rockville, Maryland, 20850
Duramed Investigational Site
Saginaw, Michigan, 48604
Duramed Investigational Site
Sylvania, Ohio, 43560
Duramed Investigational Site
Tarzana, California, 91356
Duramed Investigational Site
Webster, Texas, 77598
Duramed Investigational Site
West Los Angeles, California, 90064
Duramed Investigational Site
Westlake, California, 91361
Duramed Investigational Site
Woodbury, Minnesota, 55125
Duramed Investigational Site
Ypsilanti, Michigan, 48197
About this study
Official title: A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization
This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.
- Conditions
- Infertility
- Being tested
- DR-2011, Crinone 8%
- Keywords
- In vitro fertilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DR-2011Drug
Progesterone vaginal ring for approximately 10 weeks
Crinone 8%Drug
progesterone vaginal gel for approximately 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: DR-2011 |
| 2 | Active comparator | Not described Receives: Drug: Crinone 8% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy
Measured: 8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)
Secondary outcomes (2)
Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy
Measured: Duration of study
Adverse events
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duramed Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Duramed Research Protocol Chair, Study chair, Duramed Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615251
- Sponsor's protocol ID
- DR-PGN-302
- Status last verified
- Aug 2013
- First submitted
- 4 Feb 2008
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ginsburg ES, Jellerette-Nolan T, Daftary G, Du Y, Silverberg KM. Patient experience in a randomized trial of a weekly progesterone vaginal ring versus a daily progesterone gel for luteal support after in vitro fertilization. Fertil Steril. 2018 Nov;110(6):1101-1108.e3. doi: 10.1016/j.fertnstert.2018.07.014.
PubMed 30396554Stadtmauer L, Silverberg KM, Ginsburg ES, Weiss H, Howard B. Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization: a randomized comparative study. Fertil Steril. 2013 May;99(6):1543-9. doi: 10.1016/j.fertnstert.2012.12.052. Epub 2013 Mar 4.
PubMed 23465817
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT00615251
- Acronym / sponsor ID
- DR-PGN-302
- Conditions
- Infertility
- Keywords
- In vitro fertilization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,297 participants (actual)
- Lead sponsor
- Duramed ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 Feb 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.
This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DR-2011 |
| 2 | Active comparator | Drug: Crinone 8% |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pre-menopausal, aged 18-42 old at time of consent
- At least one cycle without fertility medication prior to screening
- Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility
- Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria)
- Others as indicated by FDA-approved protocol
Key exclusion criteria (6 listed)
- Any contraindication to progesterone therapy
- BMI > 38 kg/m2
- Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others)
- History of more than 1 failed fresh IVF cycles
- More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound)
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 |
|---|---|---|
| DR-2011Progesterone vaginal ring for approximately 10 weeks | Drug | 1 |
| Crinone 8%progesterone vaginal gel for approximately 10 weeks | Drug | 2 |
Primary outcome
Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy
Time frame: 8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)
2 secondary outcomes
Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy
Time frame: Duration of study
Adverse events
Time frame: Duration of study
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 13 Sep 2013.
- Derived from this study: PubMed 30396554Ginsburg ES, Jellerette-Nolan T, Daftary G, Du Y, Silverberg KM. Patient experience in a randomized trial of a weekly progesterone vaginal ring versus a daily progesterone gel for luteal support after in vitro fertilization. Fertil Steril. 2018 Nov;110(6):1101-1108.e3. doi: 10.1016/j.fertnstert.2018.07.014.
- Derived from this study: PubMed 23465817Stadtmauer L, Silverberg KM, Ginsburg ES, Weiss H, Howard B. Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization: a randomized comparative study. Fertil Steril. 2013 May;99(6):1543-9. doi: 10.1016/j.fertnstert.2012.12.052. Epub 2013 Mar 4.
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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.
Duramed Research Protocol Chair study chair
Duramed Research, Inc.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DR-2011 and Crinone 8% in people with Infertility, run by Duramed Research at 29 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 6 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 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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. 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?
Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy (time frame: 8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00615251, which also lists 2 linked publications.
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 13 Sep 2013.