NCT00465192

Brief Summary

This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 1994

Shorter than P25 for phase_3

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

August 31, 1994

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 1995

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 1995

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2007

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

April 23, 2007

Last Update Submit

February 28, 2017

Conditions

MenopausePostmenopausal Vaginal Atrophy

Outcome Measures

Primary Outcomes (1)

  • Relief of vaginal symptoms

    following 12 weeks of treatment.

Secondary Outcomes (3)

  • Adverse events

  • Hematology and chemisty tests, and endometrial biopsy

  • Vaginal and urethral cytology, and grading of vaginal health

Interventions

estradiol, 10 mcgDRUG
estradiol, 25 mcgDRUG
placeboDRUG

Eligibility Criteria

Age45 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally healthy
  • Postmenopausal
  • Hysterectomized or non-hysterectomized
  • Moderate or severe vaginal dryness and soreness

You may not qualify if:

  • Known, suspected, or past history of breast cancer
  • Known, suspected, or past history of hormone-dependent tumor
  • Genital bleeding of unknown etiology
  • Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
  • Vaginal infection
  • Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study
  • Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study
  • History of treatment with diethylstilbestrol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bachmann G, Lobo RA, Gut R, Nachtigall L, Notelovitz M. Efficacy of low-dose estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):67-76. doi: 10.1097/01.AOG.0000296714.12226.0f.

    PMID: 18165394DERIVED

Related Links

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 24, 2007

Study Start

August 31, 1994

Primary Completion

November 30, 1995

Study Completion

November 30, 1995

Last Updated

March 1, 2017

Record last verified: 2017-02