VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women

NCT00453089 | Unknown Phase 1

• 1 other identifier: VG-101-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Vaginal Atrophy; Vulvar Atrophy

Keywords

Chinese Herbs; Postmenopausal; Vaginal Atrophy; Vulvar Atrophy; Symptoms; Bionovo; VG101

Outcome Measures

Primary Outcomes (3)

• Change in self-reported symptoms of vaginal atrophy from baseline to 12 weeks

  4 and 12 weeks

• Change in percent superficial vaginal epithelial cells from baseline 12 weeks

  4 and 12 weeks

• Change in the pH of vaginal secretions from baseline to 12 weeks

  4 and 12 weeks

Interventions

VG101 DRUG

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between the ages of 45 and 65
• 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.
• 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)
• \< 5% superficial cells on vaginal cytologic smear.
• Vaginal pH \>5.0
• Willing to use an intravaginal cream containing Chinese herbs for the treatment of vaginal symptoms.
• Provide informed consent.

You may not qualify if:

• History of breast, uterine or ovarian cancer or melanoma.
• Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.
• Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.
• Any uterine or vaginal bleeding within the six months prior to enrollment (except following the screening Pap smear).
• Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.
• Pregnant or lactating.
• Use of any vaginal moisturizer (Replens, KY Silk-E, Astroglide Silken Secret, Senselle) within 30 days of screening.
• Use of any oral, transdermal, vaginal, or systemic estrogen or estrogen/progestin product within 30 days of screening.
• Use of raloxifene, tamoxifen or aromatase inhibitors within 12 weeks of screening.
• Current urinary tract infection (dipstick urinalysis positive for leukocyte estrace, nitrates or blood)
• History of cardiovascular disease.
• History of venous thromboembolic disease.
• Use of another investigational agent within 12 weeks of screening.
• 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.
• No access to a telephone

Sponsors & Collaborators

• Bionovo: lead

Study Sites (2)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Study Officials

• Mary Tagliaferri, MD

  Bionovo, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 28, 2007
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 8, 2012

Record last verified: 2012-02

Locations

US (2)