MenopausePhase 3NCT00108849
Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms
A Phase 3 study testing estradiol, 10 mcg in people with Menopause and Postmenopausal Vaginal Atrophy, run by Novo Nordisk A/S at 57 sites in 2 countries.
Trial summary
This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Menopause, Postmenopausal Vaginal Atrophy
- What is being tested?
- estradiol, 10 mcg
- How many people
- 309 participants
- Where
- 57 sitesin 2 countries
- Study dates
- Mar 2005to May 2007
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women whose last menstruation was at least two years previously
Who cannot join
None listed.
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
United States51 sites
Novo Nordisk Investigational Site
Alpharetta, Georgia, 30005
Novo Nordisk Investigational Site
Boise, Idaho, 83702
Novo Nordisk Investigational Site
Carmichael, California, 95608
Novo Nordisk Investigational Site
Charleston, South Carolina, 29401
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28209
Novo Nordisk Investigational Site
Clearwater, Florida, 33759
Novo Nordisk Investigational Site
Cleveland, Ohio, 44122
Novo Nordisk Investigational Site
Columbia, South Carolina, 29201
Novo Nordisk Investigational Site
Columbus, Ohio, 43210
Novo Nordisk Investigational Site
Daytona Beach, Florida, 32114
Novo Nordisk Investigational Site
Denver, Colorado, 80218
Novo Nordisk Investigational Site
Denver, Colorado, 80220
Novo Nordisk Investigational Site
Eugene, Oregon, 97401
Novo Nordisk Investigational Site
Evansville, Indiana, 47714
Novo Nordisk Investigational Site
Greenville, South Carolina, 29607
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Jackson, Tennessee, 38305
Novo Nordisk Investigational Site
Lakewood, Colorado, 80228
Novo Nordisk Investigational Site
Laurel, Maryland, 20707
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Lexington, Kentucky, 40536-0293
Novo Nordisk Investigational Site
Lincoln, Nebraska, 68510
Novo Nordisk Investigational Site
Medford, Oregon, 97504
Novo Nordisk Investigational Site
Memphis, Tennessee, 38120
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Mobile, Alabama, 36608
Novo Nordisk Investigational Site
Montgomery, Alabama, 36106
Novo Nordisk Investigational Site
Moorestown, New Jersey, 08057
Novo Nordisk Investigational Site
Mount Airy, North Carolina, 27030
Novo Nordisk Investigational Site
New London, Connecticut, 06320
Novo Nordisk Investigational Site
New York, New York, 10016
Novo Nordisk Investigational Site
Norfolk, Virginia, 23507
Novo Nordisk Investigational Site
Palm Springs, Florida, 33461
Novo Nordisk Investigational Site
Palo Alto, California, 94304
Novo Nordisk Investigational Site
Peoria, Illinois, 61615
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19114
Novo Nordisk Investigational Site
Phoenix, Arizona, 85050
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15206
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Roswell, Georgia, 30075
Novo Nordisk Investigational Site
San Diego, California, 92108
Novo Nordisk Investigational Site
San Diego, California, 92123
Novo Nordisk Investigational Site
Sandy City, Utah, 84070
Novo Nordisk Investigational Site
Spokane, Washington, 99204
Novo Nordisk Investigational Site
Spokane, Washington, 99207
Novo Nordisk Investigational Site
Tacoma, Washington, 98405
Novo Nordisk Investigational Site
Tampa, Florida, 33607
Novo Nordisk Investigational Site
Tucson, Arizona, 85712
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33409
Novo Nordisk Investigational Site
West Reading, Pennsylvania, 19611
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, 27103
Canada6 sites
Novo Nordisk Investigational Site
Kingston, K7L 4P8
Novo Nordisk Investigational Site
Montreal, H1T 1P6
Novo Nordisk Investigational Site
Québec, G1S 2L6
Novo Nordisk Investigational Site
Toronto, M5C 1R6
Novo Nordisk Investigational Site
Toronto, M5G 1Z5
Novo Nordisk Investigational Site
Winnipeg, R3A 1M3
About this study
Official title: A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms
This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.
- Conditions
- Menopause, Postmenopausal Vaginal Atrophy
- Being tested
- estradiol, 10 mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol, 10 mcgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical symptoms
Measured: after 12 months
Secondary outcomes (2)
Objective parameters (vaginal Maturation Index/Value and vaginal pH)
Hyperplasia rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2005 (estimated)
- Study startMar 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 309 participants (actual)
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
- NCT00108849
- Sponsor's protocol ID
- VAG-2195
- Status last verified
- Feb 2017
- First submitted
- 19 Apr 2005
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mettler L, Olsen PG. Long-term treatment of atrophic vaginitis with low-dose oestradiol vaginal tablets. Maturitas. 1991 Dec;14(1):23-31. doi: 10.1016/0378-5122(91)90144-f.
PubMed 1791769Derzko CM, Rohrich S, Panay N. Does age at the start of treatment for vaginal atrophy predict response to vaginal estrogen therapy? Post hoc analysis of data from a randomized clinical trial involving 205 women treated with 10 mug estradiol vaginal tablets. Menopause. 2020 Oct 5;28(2):113-118. doi: 10.1097/GME.0000000000001666.
PubMed 33038141Simon J, Nachtigall L, Ulrich LG, Eugster-Hausmann M, Gut R. Endometrial safety of ultra-low-dose estradiol vaginal tablets. Obstet Gynecol. 2010 Oct;116(4):876-883. doi: 10.1097/AOG.0b013e3181f386bb.
PubMed 20859151Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet Gynecol. 2008 Nov;112(5):1053-60. doi: 10.1097/AOG.0b013e31818aa7c3.
PubMed 18978105
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms
- ClinicalTrials.gov ID
- NCT00108849
- Acronym / sponsor ID
- VAG-2195
- Conditions
- Menopause, Postmenopausal Vaginal Atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 20 Apr 2005 (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 is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women whose last menstruation was at least two years previously
Key exclusion criteria (0 listed)
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 | – |
Primary outcome
Clinical symptoms
Time frame: after 12 months
2 secondary outcomes
Objective parameters (vaginal Maturation Index/Value and vaginal pH)
Hyperplasia rate
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 8 Feb 2017.
- Results publication: PubMed 1791769Mettler L, Olsen PG. Long-term treatment of atrophic vaginitis with low-dose oestradiol vaginal tablets. Maturitas. 1991 Dec;14(1):23-31. doi: 10.1016/0378-5122(91)90144-f.
- Derived from this study: PubMed 33038141Derzko CM, Rohrich S, Panay N. Does age at the start of treatment for vaginal atrophy predict response to vaginal estrogen therapy? Post hoc analysis of data from a randomized clinical trial involving 205 women treated with 10 mug estradiol vaginal tablets. Menopause. 2020 Oct 5;28(2):113-118. doi: 10.1097/GME.0000000000001666.
- Derived from this study: PubMed 20859151Simon J, Nachtigall L, Ulrich LG, Eugster-Hausmann M, Gut R. Endometrial safety of ultra-low-dose estradiol vaginal tablets. Obstet Gynecol. 2010 Oct;116(4):876-883. doi: 10.1097/AOG.0b013e3181f386bb.
- Derived from this study: PubMed 18978105Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet Gynecol. 2008 Nov;112(5):1053-60. doi: 10.1097/AOG.0b013e31818aa7c3.
- 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
57 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing estradiol, 10 mcg in people with Menopause and Postmenopausal Vaginal Atrophy, run by Novo Nordisk A/S at 57 sites in 2 countries.
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 1 inclusion and 0 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Clinical symptoms (time frame: after 12 months). 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 NCT00108849, which also lists 4 linked publications.
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 8 Feb 2017.