MenopausePhase 3NCT00464971
Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial
A Phase 3 study testing estradiol, 25 mcg in people with Menopause and Postmenopausal Vaginal Atrophy, run by Novo Nordisk A/S.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Menopause, Postmenopausal Vaginal Atrophy
- What is being tested?
- estradiol, 25 mcg
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 1995to 30 Nov 1996
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generally healthy
- Postmenopausal
- Hysterectomized or non-hysterectomized
- Moderate or severe vaginal dryness and soreness
- Successful completion of the study VAG/PD/009/USA
Who cannot join
- 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
About this study
Official title: Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
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.
- Conditions
- Menopause, Postmenopausal Vaginal Atrophy
- Being tested
- estradiol, 25 mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol, 25 mcgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of vaginal symptoms
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study start31 Jan 1995
- Primary completion30 Nov 1996
- Study completion30 Nov 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464971
- Sponsor's protocol ID
- VAG/PD/012/USA
- Status last verified
- Feb 2017
- First submitted
- 23 Apr 2007
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18165394
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
- ClinicalTrials.gov ID
- NCT00464971
- Acronym / sponsor ID
- VAG/PD/012/USA
- Conditions
- Menopause, Postmenopausal Vaginal Atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 1995 (actual)
- Primary completion
- 30 Nov 1996 (actual)
- Study completion
- 30 Nov 1996 (actual)
- First posted
- 24 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Generally healthy
- Postmenopausal
- Hysterectomized or non-hysterectomized
- Moderate or severe vaginal dryness and soreness
- Successful completion of the study VAG/PD/009/USA
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estradiol, 25 mcg | Drug | – |
Primary outcome
Relief of vaginal symptoms
Time frame: 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
1 secondary outcome
Vaginal health, vaginal cytology and urethral cytology
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Derived from this study: PubMed 18165394Bachmann 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing estradiol, 25 mcg in people with Menopause and Postmenopausal Vaginal Atrophy, run by Novo Nordisk A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of vaginal symptoms (time frame: over 12 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00464971, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.