Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
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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 |
- Adequate endometrial transformation [ Time Frame: Cycle Day 25 or 26 ] [ Designated as safety issue: No ]
- 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 |
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 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: | January 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Duramed Research:
|
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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013