NCT00117468

Brief Summary

This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

June 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

10 months

First QC Date

June 30, 2005

Last Update Submit

May 9, 2014

Conditions

Infertility

Keywords

luteal phase replacementoocyte donationinfertilityprogesterone

Outcome Measures

Primary Outcomes (1)

  • Adequate endometrial transformation

    Cycle Day 25 or 26

Secondary Outcomes (1)

  • Hormone levels

    Duration of study

Study Arms (2)

1

EXPERIMENTAL
Drug: DR-2011

2

ACTIVE COMPARATOR
Drug: Progesterone 8% Vaginal Gel

Interventions

DR-2011DRUG

Administered vaginally from Day 14 to Day 31

1
Progesterone 8% Vaginal GelDRUG

Administered vaginally from Cycle Day 14 to Day 31

Also known as: Crinone
2

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Not pregnant
  • Clinically or medically-induced non-functioning or surgically removed ovaries
  • Clinical investigator believes patient would be eligible for oocyte donation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duramed Investigational Site

Norfolk, Virginia, 23507, United States

Location

Related Links

MeSH Terms

Conditions

Infertility

Interventions

ProgesteroneVaginal Creams, Foams, and JelliesCrinone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid HormonesDosage FormsPharmaceutical PreparationsFeminine Hygiene ProductsEquipment and Supplies

Study Officials

  • Duramed Protocol Chair

    Duramed Research, Inc,

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 7, 2005

Study Start

June 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

US(1)