MenopausePhase 3NCT00431132

Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

A Phase 3 study testing estradiol, 10 mcg in people with Menopause and Postmenopausal Vaginal Atrophy, run by Novo Nordisk A/S at 42 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis. Read more about this study

Who is it for?: Ages 45 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Menopause, Postmenopausal Vaginal Atrophy
What is being tested?: estradiol, 10 mcg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 336 participants
Where: 42 sitesin 7 countries
Study dates: Jan 2007to Nov 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Postmenopausal women whose last menstruation was at least two years prior to the time of screening
At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity
Generally healthy

Who cannot join

Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months

Trial locations and contacts

42 sites in 7 countries.

Country

City, postcode or hospital

42 sites in 7 countries

Norway9 sites

Novo Nordisk Investigational Site
Drammen, 3015
Novo Nordisk Investigational Site
Hamar, NO-2317
Novo Nordisk Investigational Site
Larvik
Novo Nordisk Investigational Site
Oslo, 0264
Novo Nordisk Investigational Site
Sandvika, NO-1337
Novo Nordisk Investigational Site
Ski, NO-1400
Novo Nordisk Investigational Site
Stavanger, NO-4011
Novo Nordisk Investigational Site
Stavanger, NO-4020
Novo Nordisk Investigational Site
Trondheim, NO-7012

Other trials in Norway

Denmark6 sites

Novo Nordisk Investigational Site
Århus N, 8200
Novo Nordisk Investigational Site
Glostrup Municipality, 2600
Novo Nordisk Investigational Site
Herlev, 2730
Novo Nordisk Investigational Site
Hillerød, 3400
Novo Nordisk Investigational Site
Roskilde, 4000
Novo Nordisk Investigational Site
Virum, 2830

Other trials in Denmark

France6 sites

Novo Nordisk Investigational Site
Évry, 91000
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Nîmes, 30006
Novo Nordisk Investigational Site
Paris, 75005
Novo Nordisk Investigational Site
Paris, 75015
Novo Nordisk Investigational Site
Paris, 75017

Other trials in France

Sweden6 sites

Novo Nordisk Investigational Site
Gothenburg, 411 19
Novo Nordisk Investigational Site
Gothenburg, 416 85
Novo Nordisk Investigational Site
Linköping, 582 22
Novo Nordisk Investigational Site
Malmö, 217 44
Novo Nordisk Investigational Site
Norrköping, 602 32
Novo Nordisk Investigational Site
Uppsala, 751 85

Other trials in Sweden

Czechia5 sites

Novo Nordisk Investigational Site
Brno, 602 00
Novo Nordisk Investigational Site
Brno, 603 00
Novo Nordisk Investigational Site
Olomouc, 779 00
Novo Nordisk Investigational Site
Prague, 128 00
Novo Nordisk Investigational Site
Prague, 150 00

Other trials in Czechia

Finland5 sites

Novo Nordisk Investigational Site
Espoo, 02100
Novo Nordisk Investigational Site
Kuopio, 70100
Novo Nordisk Investigational Site
Oulu, 90100
Novo Nordisk Investigational Site
Tampere, 33101
Novo Nordisk Investigational Site
Turku, 20100

Other trials in Finland

Hungary5 sites

Novo Nordisk Investigational Site
Budapest, H-1034
Novo Nordisk Investigational Site
Budapest, H-1088
Novo Nordisk Investigational Site
Budapest, H-1096
Novo Nordisk Investigational Site
Pécs, H-7624
Novo Nordisk Investigational Site
Szeged, H-6725

Other trials in Hungary

About this study

Official title: A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms

This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic 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
Tablets, administered intravaginally twice weekly

Study groups in NCT00431132
Study group	Role	What they receive
Vagifem® 10 mcg	Experimental	One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks Receives: Drug: estradiol, 10 mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.
Measured: Week 52

Secondary outcomes (1)

Transvaginal Ultrasound: Endometrial Thickness
Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.
Measured: Week 0, week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Nov 2008

First posted5 Feb 2007 (estimated)
Study startJan 2007
Primary completionNov 2008
Study completionNov 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)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: 336 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00431132
Sponsor's protocol ID: VAG-1748
Other IDs: 2006-001629-24
Status last verified: Feb 2017
First submitted: 2 Feb 2007
Last updated: 15 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Simon 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 20859151
Simon 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms
ClinicalTrials.gov ID: NCT00431132
Acronym / sponsor ID: VAG-1748
Conditions: Menopause, Postmenopausal Vaginal Atrophy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 336 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 5 Feb 2007 (estimated)
Results: Posted 7 Apr 2011

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 Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vagifem® 10 mcg	Experimental	Drug: estradiol, 10 mcgOne 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks

Who may qualify

Ages: 45 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Postmenopausal women whose last menstruation was at least two years prior to the time of screening
At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity
Generally healthy

Key exclusion criteria (1 listed)

Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months

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 mcgTablets, administered intravaginally twice weekly	Drug	Vagifem® 10 mcg

Primary outcome

Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
Time frame: Week 52
The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.

1 secondary outcome

Transvaginal Ultrasound: Endometrial Thickness
Time frame: Week 0, week 52

Results and safety

Results posted to the registry on 7 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vagifem® 10 mcg	336	292

Primary outcome: Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies

Time frame: Week 52. Number. Unit: percentage of participants

Measure	Vagifem® 10 mcg n = 336
Simple hyperplasia without atypia	0
Simple hyperplasia with atypia	0
Complex hyperplasia without atypia	0
Complex hyperplasia with atypia	0
Carcinoma	0

Population analysed: Safety analyses using LOCF (last observation carried forward) were performed on the safety population, which was comprised of 336 (100%) subjects who received 52 weeks of treatment with Vagifem® 10 mcg of trial drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected over a time frame of 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vagifem® 10 mcg	14 of 336 (4.2%)	17 of 336 (5.1%)	Not reported

Limitations and caveats (from the sponsor): This was a single-arm, 12-month, open label, multicentre trial; therefore there were no comparator results available.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: 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.
Results publication: 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

42 sites in 7 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 42 sites in 7 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 3 inclusion and 1 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 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Norway, Denmark, France, Sweden, Czechia and 2 more countries. 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?

Yes. Results are posted in the registry (first posted 7 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies (time frame: Week 52). 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 NCT00431132, which also lists 2 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 15 Mar 2017.