Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00117468
First received: June 30, 2005
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.


Condition Intervention Phase
Infertility
Drug: DR-2011
Drug: Progesterone 8% Vaginal Gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Single-Center, Open-Label, Randomized, Controlled, Pharmacodynamic Study to Compare DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Adequate endometrial transformation [ Time Frame: Cycle Day 25 or 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hormone levels [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DR-2011
Administered vaginally from Day 14 to Day 31
Active Comparator: 2 Drug: Progesterone 8% Vaginal Gel
Administered vaginally from Cycle Day 14 to Day 31
Other Name: Crinone

Detailed Description:

This is a 2-arm, single-center, open-label, randomized, active-controlled study to compare the safety and efficacy of luteal phase replacement with DR-2011 to progesterone vaginal gel over an 18-day treatment period. Patients will also be required to use an estrogen patch during the course of the study. The overall study duration for each patient will be approximately 1½ months.

Luteal phase replacement will be monitored by endometrial biopsy on Cycle Day 25 or 26. In addition, serum hormonal levels will be measured at screening and at designated times from Cycle Day 14 to 31.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Not pregnant
  • Clinically or medically-induced non-functioning or surgically removed ovaries
  • Clinical investigator believes patient would be eligible for oocyte donation

Exclusion Criteria:

  • Any contraindication to progesterone or estrogen therapy
  • Undiagnosed vaginal bleeding
  • History of uterine fibroids or any other conditions that could adversely affect pregnancy success
  • Hysterectomy
  • Any contraindication to vaginal drug delivery systems
  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: NCT00117468

Locations
United States, Virginia
Duramed Investigational Site
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc,
  More Information

Additional Information:
No publications provided

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00117468     History of Changes
Other Study ID Numbers: DR-PGN-201
Study First Received: June 30, 2005
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
luteal phase replacement
oocyte donation
infertility
progesterone

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

ClinicalTrials.gov processed this record on November 19, 2014