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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117468
• Other study ID #: DR-PGN-201
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2005
• Last updated: May 9, 2014
• Start date: June 2005
• Est. completion date: April 2006

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• DR-2011
Administered vaginally from Day 14 to Day 31
• Progesterone 8% Vaginal Gel
Administered vaginally from Cycle Day 14 to Day 31

Locations

Country	Name	City	State
United States	Duramed Investigational Site	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate endometrial transformation		Cycle Day 25 or 26	No
Secondary	Hormone levels		Duration of study	No

External Links

•   MedlinePlus - Infertility