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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Drug: DR-2011
  • Progesterone vaginal ring for approximately 10 weeks
• Drug: Crinone 8%
  • progesterone vaginal gel for approximately 10 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary 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)
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• Adverse events
  • Time Frame: Duration of study
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 42 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Duramed Research Protocol Chair Study Chair Duramed Research, Inc.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00615251

Study ID Number: DR-PGN-302

ClinicalTrials.gov Identifier: NCT00615251

Health Authority: United States: Food and Drug Administration