NCT00464971

Brief Summary

This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 1995

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

January 31, 1995

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 1996

Completed
10.4 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

1.8 years

First QC Date

April 23, 2007

Last Update Submit

February 28, 2017

Conditions

MenopausePostmenopausal Vaginal Atrophy

Outcome Measures

Primary Outcomes (2)

  • Relief of vaginal symptoms

    over 12 months of treatment

  • Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels

Secondary Outcomes (1)

  • Vaginal health, vaginal cytology and urethral cytology

Interventions

estradiol, 25 mcgDRUG

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
  • Successful completion of the study VAG/PD/009/USA

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
  • Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA
  • Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 24, 2007

Study Start

January 31, 1995

Primary Completion

November 30, 1996

Study Completion

November 30, 1996

Last Updated

March 1, 2017

Record last verified: 2017-02