A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00615251
First received: February 4, 2008
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: DR-2011
Drug: Crinone 8%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 1297
Study Start Date: February 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DR-2011
Progesterone vaginal ring for approximately 10 weeks
Active Comparator: 2 Drug: Crinone 8%
progesterone vaginal gel for approximately 10 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615251

  Show 29 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Research Protocol Chair Duramed Research, Inc.
  More Information

No publications provided by Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier: NCT00615251     History of Changes
Other Study ID Numbers: DR-PGN-302
Study First Received: February 4, 2008
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
In vitro fertilization

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014