NCT00615251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,297

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 13, 2013

Status Verified

August 1, 2013

Enrollment Period

1.5 years

First QC Date

February 4, 2008

Last Update Submit

August 30, 2013

Conditions

Infertility

Keywords

In vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy

    8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)

Secondary Outcomes (2)

  • Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy

    Duration of study

  • Adverse events

    Duration of study

Study Arms (2)

1

EXPERIMENTAL
Drug: DR-2011

2

ACTIVE COMPARATOR
Drug: Crinone 8%

Interventions

DR-2011DRUG

Progesterone vaginal ring for approximately 10 weeks

1
Crinone 8%DRUG

progesterone vaginal gel for approximately 10 weeks

2

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Duramed Investigational Site

Tarzana, California, 91356, United States

Location

Duramed Investigational Site

West Los Angeles, California, 90064, United States

Location

Duramed Investigational Site

Westlake, California, 91361, United States

Location

Duramed Investigational Site

Clearwater, Florida, 33759, United States

Location

Duramed Investigational Site

Alpharetta, Georgia, 30005, United States

Location

Duramed Investigational Site

Atlanta, Georgia, 30342, United States

Location

Duramed Investigational Site

Boise, Idaho, 83702, United States

Location

Duramed Investigational Site

Chicago, Illinois, 60610, United States

Location

Duramed Investigational Site

Highland Park, Illinois, 60035, United States

Location

Duramed Investigational Site

Rockville, Maryland, 20850, United States

Location

Duramed Investigational Site

Dearborn, Michigan, 48126, United States

Location

Duramed Investigational Site

Flint, Michigan, 48503, United States

Location

Duramed Investigational Site

Rochester Hills, Michigan, 48307, United States

Location

Duramed Investigational Site

Saginaw, Michigan, 48604, United States

Location

Duramed Investigational Site

Ypsilanti, Michigan, 48197, United States

Location

Duramed Investigational Site

Woodbury, Minnesota, 55125, United States

Location

Duramed Investigational Site

Reno, Nevada, 89511, United States

Location

Duramed Investigational Site

Marlton, New Jersey, 08053, United States

Location

Duramed Investigational Site

Morristown, New Jersey, 07960, United States

Location

Duramed Investigational Site

Cincinnati, Ohio, 45209, United States

Location

Duramed Investigational Site

Sylvania, Ohio, 43560, United States

Location

Duramed Investigational Site

Columbia, South Carolina, 29201, United States

Location

Duramed Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Duramed Investigational Site

Myrtle Beach, South Carolina, 29577, United States

Location

Duramed Investigational Site

Austin, Texas, 78731, United States

Location

Duramed Investigational Site

Beaumont, Texas, 77706, United States

Location

Duramed Investigational Site

Bedford, Texas, 76022, United States

Location

Duramed Investigational Site

Webster, Texas, 77598, United States

Location

Duramed Investigational Site

Norfolk, Virginia, 23507, United States

Location

Related Publications (2)

  • Ginsburg ES, Jellerette-Nolan T, Daftary G, Du Y, Silverberg KM. Patient experience in a randomized trial of a weekly progesterone vaginal ring versus a daily progesterone gel for luteal support after in vitro fertilization. Fertil Steril. 2018 Nov;110(6):1101-1108.e3. doi: 10.1016/j.fertnstert.2018.07.014.

    PMID: 30396554DERIVED

  • Stadtmauer L, Silverberg KM, Ginsburg ES, Weiss H, Howard B. Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization: a randomized comparative study. Fertil Steril. 2013 May;99(6):1543-9. doi: 10.1016/j.fertnstert.2012.12.052. Epub 2013 Mar 4.

    PMID: 23465817DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Duramed Research Protocol Chair

    Duramed Research, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 14, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 13, 2013

Record last verified: 2013-08

Locations

US(29)