MenopausePhase 3NCT00465192
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
A Phase 3 study testing estradiol, 10 mcg and 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 for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety. 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, 10 mcg and estradiol, 25 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 1994to 30 Nov 1995
- 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
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
- 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
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
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.
- Conditions
- Menopause, Postmenopausal Vaginal Atrophy
- Being tested
- estradiol, 10 mcg, estradiol, 25 mcg, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol, 10 mcgDrug
estradiol, 25 mcgDrug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of vaginal symptoms
Measured: 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
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 Aug 1994
- Primary completion30 Nov 1995
- Study completion30 Nov 1995
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 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
- NCT00465192
- Sponsor's protocol ID
- VAG/PD/009/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
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis
- ClinicalTrials.gov ID
- NCT00465192
- Acronym / sponsor ID
- VAG/PD/009/USA
- Conditions
- Menopause, Postmenopausal Vaginal Atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 1994 (actual)
- Primary completion
- 30 Nov 1995 (actual)
- Study completion
- 30 Nov 1995 (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 for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Generally healthy
- Postmenopausal
- Hysterectomized or non-hysterectomized
- Moderate or severe vaginal dryness and soreness
Key exclusion criteria (8 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
- Vaginal infection
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, 10 mcg | Drug | – |
| estradiol, 25 mcg | Drug | – |
| placebo | Drug | – |
Primary outcome
Relief of vaginal symptoms
Time frame: following 12 weeks of treatment.
3 secondary outcomes
Adverse events
Hematology and chemisty tests, and endometrial biopsy
Vaginal and urethral cytology, and grading of vaginal health
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, 10 mcg and 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 4 inclusion and 8 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: following 12 weeks of treatment.). 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 NCT00465192, 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; AzTrials last refreshed its copy on 8 Nov 2026.