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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00117468
First Posted: July 7, 2005
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Teva Pharmaceutical Industries
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Hormone levels [ Time Frame: Duration of study ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00117468     History of Changes
Other Study ID Numbers: DR-PGN-201
First Submitted: June 30, 2005
First Posted: July 7, 2005
Last Update Posted: May 12, 2014
Last Verified: May 2014

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

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