A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization - Tabular View

Tracking Information

First Received Date ^ICMJE

February 4, 2008

Last Updated Date

October 8, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy [ Time Frame: 8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00615251 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization

Official Title ^ICMJE

A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization

Brief Summary

This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Infertility

Intervention ^ICMJE

Drug: DR-2011
Drug: Crinone 8%

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1300

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Pre-menopausal, aged 18-42 old at time of consent
At least one cycle without fertility medication prior to screening
Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility
Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria)
Others as indicated by FDA-approved protocol

Exclusion Criteria:

Any contraindication to progesterone therapy
BMI > 38 kg/m2
Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others)
History of more than 1 failed fresh IVF cycles
More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound)
Others as indicated by FDA-approved protocol

Gender

Female

Ages

18 Years to 42 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00615251

Responsible Party

Duramed Research, Inc., Duramed Rearch, Inc.

Study ID Numbers ^ICMJE

DR-PGN-302

Study Sponsor ^ICMJE

Duramed Research

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Duramed Research Protocol Chair

Duramed Research, Inc.

Information Provided By

Duramed Research

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP