Vulvo Vaginal AtrophyNCT01502527
A Twelve Week Study to Investigate the Efficacy of Femarelle®, for the Treatment of Post Menopausal Vaginal Atrophy
A study testing Femarelle in people with Vulvo Vaginal Atrophy, run by Dr. Lila Nachtigall Rapid Medical Research, New York at 1 site in United States.
Trial summary
Based on previous data published on the SERM properties of Femarelle, the investigators hypothesized that Femarelle could be a potential treatment for Vulvo-vaginal atrophy(VVA) symptoms. The current study was a pilot study to examine the effect of Femarelle® on VVA symptoms in symptomatic post-menopausal women. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvo Vaginal Atrophy
- What is being tested?
- Femarelle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2012
- 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 40 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy post menopausal women between the ages of 40-85+yrs who complain of vaginal dryness with at least three urogenital symptoms from the following: vaginal dryness, vaginal irritation, vaginal soreness, dysuria, dyspareunia, bleeding with coitus \& one of these symptoms must be moderate to severe as determined by patient, Moderate: discomforting and aware of it with activities. Severe: discomforting enough to interfere with activities Activities include sitting, walking, running, urinating, as well as sexual activity
- BMI 18-34 (inclusive).
- Patients having a LMP at least one year ago, either natural or surgical.
- Patients with a normal mammogram within 9 months prior to enrollment.
- Patients able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Patients who provide written informed consent to participate in the study.
Show all 11Show fewer
- FSH > 40 mIU/m.
- Estradiol < 20 pg/ml.
- Vaginal PH > 5.
- < 5% superficial cells as assessed by vaginal cytology.
- Normal pelvic and breast exams by investigator.
Who cannot join
- Patients using HRT (cannot have used for past 3 months).
- Patients consuming over the last three months high soy diet or any foods or other compounds that are sold as remedies for the post menopausal symptoms.
- Any history of significant cancer or pre-cancer, neurological, renal, cardiovascular, respiratory (e.g. asthma, COPD), hypercoagulability, hematopoietic disease, immune deficiency or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
- Patients with any clinically significant abnormality upon examination at screening visit.
- Patients with a known history of drug or alcohol abuse.
- Known hypersensitivity and/or allergy to soy or flax.
- Participation in another clinical trial within the past 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rapid Medical Research of New York
New York, New York, 10016
About this study
Official title: An Open Labeled Prospective Study to Investigate the Effect of Femarelle® on Vulvo-vaginal Atrophy Symptoms
Based on previous data published on the SERM properties of Femarelle, the investigators hypothesized that Femarelle could be a potential treatment for Vulvo-vaginal atrophy(VVA) symptoms. The current study was a pilot study to examine the effect of Femarelle® on VVA symptoms in symptomatic post-menopausal women.
Read the detailed description
Post-menopausal women aged 54-77, with vaginal atrophy (< 5% superficial cells on cervical cytology) with at least one moderate-to-severe VVA symptom (dryness, irritation, soreness, dysuria, dyspareunia, or bleeding with coitus), will be recruited for a 12-week open-label pilot study. The study protocol was approved by Schulman Associates IRB.Femarelle will be given twice daily and subjective symptoms as well as objective measures like inspection and vaginal pH will be measured.
- Conditions
- Vulvo Vaginal Atrophy
- Being tested
- Femarelle
- Keywords
- Vulvo vaginal atrophy, Femarelle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemarelleDietary supplement
Also called DT56a
Twice daily oral treatment with Femarelle
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Femarelle | Experimental | An open labeled , twice daily treatment with Femarelle Receives: Dietary Supplement: Femarelle |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in VVA symptoms
Subjective and objective measures of VVA
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 posted30 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvo Vaginal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lila Nachtigall Rapid Medical Research, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Se-cure Pharmaceuticals Ltd.
- Responsible party
- Sponsor
- Investigators
- Lila Nachtigall, MD, Principal investigator, Rapid Medical Research of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502527
- Sponsor's protocol ID
- SCS - 001
- Status last verified
- Mar 2017
- First submitted
- 29 Dec 2011
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Labeled Prospective Study to Investigate the Effect of Femarelle® on Vulvo-vaginal Atrophy Symptoms
- ClinicalTrials.gov ID
- NCT01502527
- Acronym / sponsor ID
- SCS - 001
- Conditions
- Vulvo Vaginal Atrophy
- Keywords
- Vulvo vaginal atrophy, Femarelle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dr. Lila Nachtigall Rapid Medical Research, New YorkUniversity, hospital or other
- Collaborators
- Se-cure Pharmaceuticals Ltd.
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 Dec 2011 (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.
Based on previous data published on the SERM properties of Femarelle, the investigators hypothesized that Femarelle could be a potential treatment for Vulvo-vaginal atrophy(VVA) symptoms. The current study was a pilot study to examine the effect of Femarelle® on VVA symptoms in symptomatic post-menopausal women.
Detailed description
Post-menopausal women aged 54-77, with vaginal atrophy (< 5% superficial cells on cervical cytology) with at least one moderate-to-severe VVA symptom (dryness, irritation, soreness, dysuria, dyspareunia, or bleeding with coitus), will be recruited for a 12-week open-label pilot study. The study protocol was approved by Schulman Associates IRB.Femarelle will be given twice daily and subjective symptoms as well as objective measures like inspection and vaginal pH will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Femarelle | Experimental | Dietary Supplement: FemarelleAn open labeled , twice daily treatment with Femarelle |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy post menopausal women between the ages of 40-85+yrs who complain of vaginal dryness with at least three urogenital symptoms from the following: vaginal dryness, vaginal irritation, vaginal soreness, dysuria, dyspareunia, bleeding with coitus \& one of these symptoms must be moderate to severe as determined by patient, Moderate: discomforting and aware of it with activities. Severe: discomforting enough to interfere with activities Activities include sitting, walking, running, urinating, as well as sexual activity
- BMI 18-34 (inclusive).
- Patients having a LMP at least one year ago, either natural or surgical.
- Patients with a normal mammogram within 9 months prior to enrollment.
- Patients able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Key exclusion criteria (7 listed)
- Patients using HRT (cannot have used for past 3 months).
- Patients consuming over the last three months high soy diet or any foods or other compounds that are sold as remedies for the post menopausal symptoms.
- Any history of significant cancer or pre-cancer, neurological, renal, cardiovascular, respiratory (e.g. asthma, COPD), hypercoagulability, hematopoietic disease, immune deficiency or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
- Patients with any clinically significant abnormality upon examination at screening visit.
- Patients with a known history of drug or alcohol abuse.
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 |
|---|---|---|
| FemarelleAlso: DT56aTwice daily oral treatment with Femarelle | Dietary supplement | Treatment with Femarelle |
Primary outcome
improvement in VVA symptoms
Time frame: 12 weeks
Subjective and objective measures of VVA
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 20 Mar 2017.
Related trials for Vulvo Vaginal Atrophy
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer
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.
Lila Nachtigall, MD principal investigator
Rapid Medical Research of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femarelle in people with Vulvo Vaginal Atrophy, run by Dr. Lila Nachtigall Rapid Medical Research, New York at 1 site in United States.
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 11 inclusion and 7 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 20 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 1 site in United States. 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?
improvement in VVA symptoms (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2017.