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

Duramed Research

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Drug: DR-2011; Drug: Crinone 8%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00615251

DR-PGN-302

Details and patient eligibility

About

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.

Enrollment: 1,297 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,297 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: DR-2011

2

Active Comparator group

Treatment:

Drug: Crinone 8%