Vulvo Vaginal Atrophy Clinical Trial
Official title:
An Open Labeled Prospective Study to Investigate the Effect of Femarelle® on Vulvo-vaginal Atrophy Symptoms
| Verified date | March 2017 |
| Source | Dr. Lila Nachtigall Rapid Medical Research, New York |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 40 Years to 85 Years |
| Eligibility |
Inclusion Criteria: 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. - 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. Exclusion Criteria: 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Rapid Medical Research of New York | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Dr. Lila Nachtigall Rapid Medical Research, New York | Se-cure Pharmaceuticals Ltd. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | improvement in VVA symptoms | Subjective and objective measures of VVA | 12 weeks |