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Completed

NCT Number: NCT00117468

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

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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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Duramed Investigational Site

Norfolk, Virginia, 23507, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DR-2011

Drug

Administered vaginally from Day 14 to Day 31

Progesterone 8% Vaginal Gel

Drug

Administered vaginally from Cycle Day 14 to Day 31

Other names: Crinone

Primary outcomes

  1. Adequate endometrial transformation

    Time frame: Cycle Day 25 or 26

Secondary outcomes

  1. Hormone levels

    Time frame: Duration of study

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 7, 2005
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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