Atrophy of VaginaNCT02887885
Sustainability of Vaginal Estrogen Therapy in Postmenopausal Women
An observational study of Atrophy of Vagina and Postmenopause, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Atrophy of Vagina, Postmenopause
- What is being tested?
- Gynoflor
- Type of treatment
- Pill or oral medicine
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jan 2018to 10 Apr 2020
- Phase
- Observational
- 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: postmenopausal women
Who may be able to join
- Postmenopausal women (last menstrual period more than 12 months ago or having undergone bilateral ovariectomy)
- Age ≥ 18 years
- Diagnosis of moderate to severe vaginal atrophy at screening visit with VMI < 50% and vaginal pH > 4.5
- At least one subjective symptom of vaginal atrophy (dryness, pain/burning sensation, pruritus, discharge, dyspareunia) related to a score of ≥ 65 on the visual analogue scale (VAS)
- Indication for vaginal treatment with Gynoflor® (100 million viable L. acidophilus KS 400 and estriol 30 mcg per application) for 6 weeks because of symptomatic vaginal atrophy after menopause: 1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday).
- Informed consent as documented by signature
Who cannot join
- Administration of any form of oral/transdermal hormone therapy (HT) or selective estrogen receptor modulators (SERM) or phytoestrogens within 2 months prior to entry into or during the study.
- Any use of over-the-counter vaginal products within 1 week prior to and during entry the study.
- Known hypersensitivity or allergy to the investigational product
- Estrogen dependent malignancy
- Undiagnosed genital bleeding
- Active thromboembolism
Show all 18Show fewer
- Active vulvovaginal Candidiasis, Trichomonas vaginitis or bacterial vaginitis based on light microscopy of vaginal secretions, vaginal pH, whiff test and KOH preparation
- Active sexually transmitted infections (STI) including herpes simplex viral infection, gonorrhoea and Chlamydia.
- Active urinary tract infection.
- Pessary-users
- Immunocompromised patients including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents
- Severe liver and/or kidney disease
- Diabetes mellitus
- Polyneuropathy
- Skin disease affecting vulva or vagina, e.g. lichen sclerosus
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern
Bern, 3010
About this study
Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women
Read the detailed description
Within this trial 50 postmenopausal women receive a vaginal estrogen therapy as treatment for symptomatic vaginal atrophy. The sustainability of vaginal estrogen therapy after the end of therapy has not yet been investigated.
All participants will be asked to come for the following 7 visits.
- Visit 1: Standard Gynecological examination; Inclusion and exclusion criteria check
- Visit 2: Handing out of Gynoflor (estrogen) for a 6 weeks treatment.
- Visit 3 (Study Start): After using the vaginal estrogen for 6 weeks, a vaginal swap will be done to measure the vaginal maturation index (VMI). The participants will also receive a questionnaire to define some subjective parameters. The parameters measured at visit 1 will count as reference. The estrogen therapy will now be sustained.
- Visit 4-6: Measuring of the VMI and handing out the questionnaires to define subjective parameters.
- Conditions
- Atrophy of Vagina, Postmenopause
- Being tested
- Gynoflor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GynoflorDrug
1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday) for 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in vaginal maturation index (VMI)
Measured: 0 weeks, 4 weeks
Secondary outcomes (6)
Mean change in VMI
Measured: 0 weeks,1 week, 2 weeks, 6 weeks
Mean change in vaginal pH
Measured: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Number of lactobacilli
Measured: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Lactobacillary grade (LBG),
Measured: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Mean change in the most bothersome moderate and severe symptom of vaginal atrophy (MBS) . The symptoms include dryness, pain/burning sensation, pruritus, discharge, and dyspareunia.
Measured: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Mean change in health-related quality of life (EQ-5D-5L). Mean change in Female Sexual Function Index (FSFI).
Measured: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study start22 Jan 2018
- Primary completion19 Mar 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrophy of VaginaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Medinova AG
- Responsible party
- Sponsor
- Investigators
- Petra Stute, Prof, Principal investigator, University Hospital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887885
- Sponsor's protocol ID
- 2016-00380
- Other IDs
- 2016
- Status last verified
- Apr 2022
- First submitted
- 17 Aug 2016
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.
PubMed 23985562McEndree B. Clinical application of the vaginal maturation index. Nurse Pract. 1999 Sep;24(9):48, 51-2, 55-6.
PubMed 10507070
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainability of Vaginal Estrogen Therapy in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02887885
- Acronym / sponsor ID
- 2016-00380
- Conditions
- Atrophy of Vagina, Postmenopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Medinova AG
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 2 Sep 2016 (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.
Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women
Detailed description
Within this trial 50 postmenopausal women receive a vaginal estrogen therapy as treatment for symptomatic vaginal atrophy. The sustainability of vaginal estrogen therapy after the end of therapy has not yet been investigated.
All participants will be asked to come for the following 7 visits.
- Visit 1: Standard Gynecological examination; Inclusion and exclusion criteria check
- Visit 2: Handing out of Gynoflor (estrogen) for a 6 weeks treatment.
- Visit 3 (Study Start): After using the vaginal estrogen for 6 weeks, a vaginal swap will be done to measure the vaginal maturation index (VMI). The participants will also receive a questionnaire to define some subjective parameters. The parameters measured at visit 1 will count as reference. The estrogen therapy will now be sustained.
- Visit 4-6: Measuring of the VMI and handing out the questionnaires to define subjective parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- postmenopausal women
Key inclusion criteria (6 listed)
- Postmenopausal women (last menstrual period more than 12 months ago or having undergone bilateral ovariectomy)
- Age ≥ 18 years
- Diagnosis of moderate to severe vaginal atrophy at screening visit with VMI < 50% and vaginal pH > 4.5
- At least one subjective symptom of vaginal atrophy (dryness, pain/burning sensation, pruritus, discharge, dyspareunia) related to a score of ≥ 65 on the visual analogue scale (VAS)
- Indication for vaginal treatment with Gynoflor® (100 million viable L. acidophilus KS 400 and estriol 30 mcg per application) for 6 weeks because of symptomatic vaginal atrophy after menopause: 1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday).
Key exclusion criteria (18 listed)
- Administration of any form of oral/transdermal hormone therapy (HT) or selective estrogen receptor modulators (SERM) or phytoestrogens within 2 months prior to entry into or during the study.
- Any use of over-the-counter vaginal products within 1 week prior to and during entry the study.
- Known hypersensitivity or allergy to the investigational product
- Estrogen dependent malignancy
- Undiagnosed genital bleeding
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 |
|---|---|---|
| Gynoflor1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday) for 6 weeks | Drug | – |
Primary outcome
Mean change in vaginal maturation index (VMI)
Time frame: 0 weeks, 4 weeks
6 secondary outcomes
Mean change in VMI
Time frame: 0 weeks,1 week, 2 weeks, 6 weeks
Mean change in vaginal pH
Time frame: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Number of lactobacilli
Time frame: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Lactobacillary grade (LBG),
Time frame: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Mean change in the most bothersome moderate and severe symptom of vaginal atrophy (MBS) . The symptoms include dryness, pain/burning sensation, pruritus, discharge, and dyspareunia.
Time frame: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
Mean change in health-related quality of life (EQ-5D-5L). Mean change in Female Sexual Function Index (FSFI).
Time frame: 0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks
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 27 Apr 2022.
- Background: PubMed 23985562Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.
- Background: PubMed 10507070McEndree B. Clinical application of the vaginal maturation index. Nurse Pract. 1999 Sep;24(9):48, 51-2, 55-6.
- Individual participant dataSharing planned: No
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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.
Petra Stute, Prof principal investigator
University Hospital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrophy of Vagina and Postmenopause, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 6 inclusion and 18 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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.
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?
Mean change in vaginal maturation index (VMI) (time frame: 0 weeks, 4 weeks). 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 NCT02887885, 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 27 Apr 2022.