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Sponsored by: |
Duramed Research |
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Information provided by: | Duramed Research |
ClinicalTrials.gov Identifier: | NCT00117468 |
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 |
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Infertility |
Drug: DR-2011 Drug: Progesterone 8% Vaginal Gel |
Phase II |
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 |
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 |
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1: Experimental |
Drug: DR-2011
Administered vaginally from Day 14 to Day 31
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2: Active Comparator |
Drug: Progesterone 8% Vaginal Gel
Administered vaginally from Cycle Day 14 to Day 31
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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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
luteal phase replacement oocyte donation infertility progesterone |
Genital Diseases, Female Infertility Progesterone Hormone Antagonists |
Progestins Hormones, Hormone Substitutes, and Hormone Antagonists Genital Diseases, Male Hormones |
Genital Diseases, Female Infertility Progesterone Progestins Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Genital Diseases, Male Hormones Pharmacologic Actions |