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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-04-30

Brief Summary

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This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.

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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

DR-2011

Intervention Type DRUG

Administered vaginally from Day 14 to Day 31

2

Group Type ACTIVE_COMPARATOR

Progesterone 8% Vaginal Gel

Intervention Type DRUG

Administered vaginally from Cycle Day 14 to Day 31

Interventions

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DR-2011

Administered vaginally from Day 14 to Day 31

Intervention Type DRUG

Progesterone 8% Vaginal Gel

Administered vaginally from Cycle Day 14 to Day 31

Intervention Type DRUG

Other Intervention Names

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Crinone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No