Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
Information source: Duramed Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: DR-2011 (Drug); Progesterone 8% Vaginal Gel (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Duramed Research Official(s) and/or principal investigator(s):
Duramed Protocol Chair, Study Chair, Affiliation: Duramed Research, Inc,
Summary
This is a single-center, open-label, randomized, active-controlled study to compare DR-2011
to progesterone vaginal gel for luteal phase replacement.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Adequate endometrial transformation
Secondary outcome: Hormone levels
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
Duramed Investigational Site, Norfolk, Virginia 23507, United States
Additional Information
MedlinePlus - Infertility
Starting date: June 2005
Ending date: April 2006
Last updated: February 29, 2008
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