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

Sponsored by:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00117468

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 II

MedlinePlus related topics: Infertility

Drug Information available for: Progesterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Duramed Research:

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
1: Experimental	Drug: DR-2011 Administered vaginally from Day 14 to Day 31
2: Active Comparator	Drug: Progesterone 8% Vaginal Gel Administered vaginally from Cycle Day 14 to Day 31

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

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:

MedlinePlus - Infertility This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Duramed Research, Inc. ( Duramed Protocol Chair )
Study ID Numbers:	DR-PGN-201
Study First Received:	June 30, 2005
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00117468 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

luteal phase replacement
oocyte donation
infertility
progesterone

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Progesterone
Hormone Antagonists

Progestins
Hormones, Hormone Substitutes, and Hormone Antagonists
Genital Diseases, Male
Hormones

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Progesterone
Progestins
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Genital Diseases, Male
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009