Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00453089
Other study ID # VG-101-001
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received March 26, 2007
Last updated February 6, 2012
Start date June 2012
Est. completion date August 2013

Study information

Verified date February 2012
Source Bionovo
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To conduct a prospective, randomized, blinded, placebo controlled, dose escalation clinical trial in 4 cohorts of 10 postmenopausal women (total N=40) aged 45 to 65 years with at least one menopausal vaginal symptom, vaginal pH > 5.0 and > 20% parabasal vaginal epithelial cells.


Description:

Primary Aims:

1. the optimal dose of VG101 based on the highest of 4 proposed dose levels that is not associated with unacceptable toxicity during 12 weeks of treatment. Toxicity will be based on National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 3. Unacceptable toxicity will be defined as the occurrence of any Grade 3, 4, of 5 toxicity that is possibly or probably associated with study drug or any other unacceptable toxicity as determined by the Data and Safety Monitoring Board.

2. Specific potential adverse effects of VG101

Secondary Aims:

1. the preliminary efficacy of VG101 to:

- relieve vulvar and/or vaginal dryness,

- relieve vulvar and/or vaginal irritation

- relieve vulvar and/or vaginal itching

- relieve vulvar and/or vaginal discharge

- relieve dyspareunia

- improve sexual function

- relieve dysuria

- reduce frequency of urinary incontinence

- improve quality of life

- improve the physical examination assessment of vaginal atrophy

- reduce vaginal fluid pH

- improve the proportion of superficial vaginal epithelial cells

2. participant adherence to VG101 administration


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date August 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria:

1. Women between the ages of 45 and 65

2. Postmenopausal documented by: (a) at least one year of amenorrhea; (b) 6- 12 months of amenorrhea with serum FSH > 40 IU/ml; (c) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or (d) hysterectomy with serum FSH levels > 40 IU/ml.

3. Self-report at least one moderate to severe symptom of vulvar or vaginal atrophy from the following list:

- Vaginal dryness (none, mild, moderate or severe)

- Vaginal and/or vulvar discomfort (none, mild, moderate, severe)

- Vaginal and/or vulvar irritation (none, mild, moderate, severe)

- Vaginal itching (none, mild, moderate, severe)

- Vaginal pain associated with sexual activity (none, mild, moderate or severe)

4. < 5% superficial cells on vaginal cytologic smear.

5. Vaginal pH >5.0

6. Willing to use an intravaginal cream containing Chinese herbs for the treatment of vaginal symptoms.

7. Provide informed consent.

Exclusion Criteria:

1. History of breast, uterine or ovarian cancer or melanoma.

2. Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.

3. Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.

4. Any uterine or vaginal bleeding within the six months prior to enrollment (except following the screening Pap smear).

5. Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.

6. Pregnant or lactating.

7. Use of any vaginal moisturizer (Replens, KY Silk-E, Astroglide Silken Secret, Senselle) within 30 days of screening.

8. Use of any oral, transdermal, vaginal, or systemic estrogen or estrogen/progestin product within 30 days of screening.

9. Use of raloxifene, tamoxifen or aromatase inhibitors within 12 weeks of screening.

10. Current urinary tract infection (dipstick urinalysis positive for leukocyte estrace, nitrates or blood)

11. History of cardiovascular disease.

12. History of venous thromboembolic disease.

13. Use of another investigational agent within 12 weeks of screening.

14. Any medical or psychiatric condition that, in the investigator's opinion, would preclude the participant from completing questionnaires or measures, adhering to the protocol or completing the trial, including limited English literacy, severe illness, plans to move, substance abuse, significant psychiatric problems, or dementia.

15. No access to a telephone

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
VG101


Locations

Country Name City State
United States University of Alabama, Birmingham Birmingham Alabama
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Bionovo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in self-reported symptoms of vaginal atrophy from baseline to 12 weeks 4 and 12 weeks No
Primary Change in percent superficial vaginal epithelial cells from baseline 12 weeks 4 and 12 weeks No
Primary Change in the pH of vaginal secretions from baseline to 12 weeks 4 and 12 weeks No
See also
  Status Clinical Trial Phase
Completed NCT06136975 - Low-level Laser Therapy for Genitourinary Syndromes and Stress Urinary Incontinence
Recruiting NCT04081805 - LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2) N/A
Completed NCT04039555 - Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER) N/A
Active, not recruiting NCT02704741 - Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments N/A
Completed NCT01975129 - A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin Phase 2
Completed NCT04735549 - Vulvovaginal Atrophy Correction Using Neodymium Laser N/A
Completed NCT04079218 - Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial Phase 4
Completed NCT03063684 - Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus N/A
Recruiting NCT05953090 - VALOR: Vaginal Atrophy & Long-term Observation of Recovery N/A
Not yet recruiting NCT05483634 - Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
Completed NCT04717245 - Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment N/A
Completed NCT02967510 - Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy Phase 2
Completed NCT02937805 - Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes N/A
Not yet recruiting NCT02571127 - Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness. Phase 4
Completed NCT00238732 - Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause Phase 3
Completed NCT02413008 - A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting Phase 2
Completed NCT03493126 - Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function Phase 4
Not yet recruiting NCT03238053 - Laser Treatment of Genito-urinary Syndrome in Women N/A
Terminated NCT01753102 - Efficacy and Safety Of Spil's Estradiol Vaginal Tablet Phase 3
Terminated NCT05627791 - Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman Phase 2/Phase 3