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

Purpose

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.

Condition	Intervention	Phase
Infertility	Drug: DR-2011 Drug: Crinone 8%	Phase III

MedlinePlus related topics:

Infertility

ChemIDplus related topics:

Progesterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Duramed Research:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1300
Study Start Date:	February 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: DR-2011 Progesterone vaginal ring for approximately 10 weeks
2: Active Comparator	Drug: Crinone 8% progesterone vaginal gel for approximately 10 weeks

Eligibility

Ages Eligible for Study:	18 Years to 42 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615251

Show 28 Study Locations

Sponsors and Collaborators

Duramed Research

Investigators


Study Chair:	Duramed Research Protocol Chair	Duramed Research, Inc.

More Information

Responsible Party:	Duramed Rearch, Inc. ( Duramed Research, Inc. )
Study ID Numbers:	DR-PGN-302
First Received:	February 4, 2008
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00615251
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

In vitro fertilization

Study placed in the following topic categories:

Genital Diseases, Female

Infertility

Progesterone

Genital Diseases, Male

Additional relevant MeSH terms:

Progestins

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2008

Sponsored by:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00615251