Vulvovaginal AtrophyNCT04887701
Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women
A study testing Non-hormonal vaginal device therapy in people with Vulvovaginal Atrophy, run by Madorra at 3 sites in Australia.
Trial summary
Randomized (1:1), double-blind, sham-controlled, 2-arm parallel study comparing effectiveness and safety of non-hormonal medical device versus sham device to treat VVA in post-menopausal women. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Non-hormonal vaginal device therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 3 sitesAustralia
- Study dates
- 9 Jul 2021to 22 Aug 2022
- Phase
- Interventional
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with menopause defined by last menstrual period at least 12 months prior to screening, or 6 months of amenorrhea with serum FSH levels > 40 mIU/ml, or 8 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- Sexually active women.
- Participant experiencing subjective moderate-to-severe vaginal pain with sexual intercourse.
- Participant experiencing subjective moderate-to-severe vaginal dryness.
- Gynecological exam confirming vaginal atrophy.
- Willingness to give voluntary written informed consent to participate in the study and comply with protocol requirements.
Who cannot join
- Use of systemic or local estrogen therapy, currently or in the last 6 months or planned use during the study.
- Use of any other treatment for vaginal atrophy, 6 weeks prior to enrollment or planned during the study period.
- Investigational drugs and also prescription and nonprescription medications/remedies known to treat VVA within 60 days of enrollment or during the study.
- Vaginal stenosis.
- Pelvic floor disorders.
- Prior pelvic radiation therapy including radiation or surgery to the vulva/vagina.
Show all 13Show fewer
- Active urinary tract, yeast, or other active gynecologic infections.
- Active connective tissue disorders such as lupus or Sjogren's syndrome.
- Active malignancies.
- Diagnosis of vulvodynia or other pelvic pain in the vagina or vulvar area.
- Vulvar dermatoses.
- Laser or radio frequency vaginal rejuvenation treatment or planned treatment during the study.
- Any medical condition that, in the investigator's opinion, would interfere with their participation and/or completion in the study.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Goldfields Urology
Bendigo, Victoria, 3550
Royal Women's Hospital
Melbourne, Victoria, 3052
North Shore Private Hospital
Sydney, New South Wales, 2065
About this study
Official title: Clinical Outcomes and Safety of a Non-hormonal Medical Device Versus a Sham Device on the Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women Who Have Failed, Refused, or Are Contraindicated for Hormone Therapy
Randomized (1:1), double-blind, sham-controlled, 2-arm parallel study comparing effectiveness and safety of non-hormonal medical device versus sham device to treat VVA in post-menopausal women.
Read the detailed description
After screening and baseline assessment, participants, ages 21 to 65 years of age, will be randomized and followed for a 12-week intervention period. After the primary endpoint evaluation at week 12, each participant in both arms will immediately commence an open label period using an Active device for week 13 to 1 year to collect further effectiveness and safety data.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Non-hormonal vaginal device therapy, Sham vaginal device therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-hormonal vaginal device therapyDevice
Experimental Active Therapy
Sham vaginal device therapyDevice
Sham Comparator
| Study group | Role | What they receive |
|---|---|---|
| Non-hormonal device therapy | Experimental | Daily non-hormonal device therapy Receives: Device: Non-hormonal vaginal device therapy |
| Sham Therapy | Sham comparator | Daily non-hormonal sham device therapy Receives: Device: Sham vaginal device therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Assessed Changes in VVA
Will determine by comparing the mean change between the two arms of the study in clinician assessed changes of VVA by the Vaginal Health Index (VHI). The VHI gives a numerical score (1-5) for each of the 5 parameters measured:
issue elasticity, vaginal fluid, PH, mucosa, and vaginal moisture.
Measured: Baseline to 12 weeks
Patient Reported VAS Score
Mean change in the Vaginal Assessment Scale (VAS). The VAS is a scale from 0 to 3 with 0 being no symptoms and 3 being severe symptoms.
Measured: Baseline to 12 weeks
Secondary outcomes (1)
Responder Rate PGI-I
The proportion of patients in the two arms of the study achieving improvement in the patient global impression of improvement (PGI-I), (much or very much improved) at 12 weeks post-treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start9 Jul 2021
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
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 Vulvovaginal AtrophyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madorra
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodney Baber, MD, Principal investigator, North Shore Private Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887701
- Sponsor's protocol ID
- CLN-201
- Status last verified
- Jan 2023
- First submitted
- 10 May 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hickey M, Baber R, Eden J, Brennan J, Bateson D, Goldman M, Rockweiler H, Dreon D. Safety and effectiveness of a novel home-use therapeutic ultrasound device for the treatment of vaginal dryness in postmenopausal women: a pilot study. Menopause. 2023 Apr 1;30(4):383-392. doi: 10.1097/GME.0000000000002157. Epub 2023 Feb 8.
PubMed 36749915
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Safety of a Non-hormonal Medical Device Versus a Sham Device on the Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women Who Have Failed, Refused, or Are Contraindicated for Hormone Therapy
- ClinicalTrials.gov ID
- NCT04887701
- Acronym / sponsor ID
- CLN-201
- Conditions
- Vulvovaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- MadorraIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 14 May 2021 (actual)
- 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.
Randomized (1:1), double-blind, sham-controlled, 2-arm parallel study comparing effectiveness and safety of non-hormonal medical device versus sham device to treat VVA in post-menopausal women.
Detailed description
After screening and baseline assessment, participants, ages 21 to 65 years of age, will be randomized and followed for a 12-week intervention period. After the primary endpoint evaluation at week 12, each participant in both arms will immediately commence an open label period using an Active device for week 13 to 1 year to collect further effectiveness and safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-hormonal device therapy | Experimental | Device: Non-hormonal vaginal device therapyDaily non-hormonal device therapy |
| Sham Therapy | Sham comparator | Device: Sham vaginal device therapyDaily non-hormonal sham device therapy |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women with menopause defined by last menstrual period at least 12 months prior to screening, or 6 months of amenorrhea with serum FSH levels > 40 mIU/ml, or 8 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- Sexually active women.
- Participant experiencing subjective moderate-to-severe vaginal pain with sexual intercourse.
- Participant experiencing subjective moderate-to-severe vaginal dryness.
- Gynecological exam confirming vaginal atrophy.
Key exclusion criteria (13 listed)
- Use of systemic or local estrogen therapy, currently or in the last 6 months or planned use during the study.
- Use of any other treatment for vaginal atrophy, 6 weeks prior to enrollment or planned during the study period.
- Investigational drugs and also prescription and nonprescription medications/remedies known to treat VVA within 60 days of enrollment or during the study.
- Vaginal stenosis.
- Pelvic floor disorders.
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 |
|---|---|---|
| Non-hormonal vaginal device therapyExperimental Active Therapy | Device | Non-hormonal device therapy |
| Sham vaginal device therapySham Comparator | Device | Sham Therapy |
Primary outcome
Clinician Assessed Changes in VVA
Time frame: Baseline to 12 weeks
Will determine by comparing the mean change between the two arms of the study in clinician assessed changes of VVA by the Vaginal Health Index (VHI). The VHI gives a numerical score (1-5) for each of the 5 parameters measured: issue elasticity, vaginal fluid, PH, mucosa, and vaginal moisture.
Patient Reported VAS Score
Time frame: Baseline to 12 weeks
Mean change in the Vaginal Assessment Scale (VAS). The VAS is a scale from 0 to 3 with 0 being no symptoms and 3 being severe symptoms.
1 secondary outcome
Responder Rate PGI-I
Time frame: 12 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 13 Jan 2023.
- Derived from this study: PubMed 36749915Hickey M, Baber R, Eden J, Brennan J, Bateson D, Goldman M, Rockweiler H, Dreon D. Safety and effectiveness of a novel home-use therapeutic ultrasound device for the treatment of vaginal dryness in postmenopausal women: a pilot study. Menopause. 2023 Apr 1;30(4):383-392. doi: 10.1097/GME.0000000000002157. Epub 2023 Feb 8.
- 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.
Rodney Baber, MD principal investigator
North Shore Private Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-hormonal vaginal device therapy in people with Vulvovaginal Atrophy, run by Madorra at 3 sites in Australia.
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 13 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 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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. Some participants in this study may receive a placebo. 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?
Clinician Assessed Changes in VVA (time frame: Baseline to 12 weeks). 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 NCT04887701, 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 13 Jan 2023.