We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376349
First Posted: June 20, 2011
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Mayo Clinic
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  Purpose

RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors.

PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal cancer survivors with vaginal symptoms.


Condition Intervention Phase
Breast Cancer Gynecologic Cancer Drug: prasterone Other: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo- Controlled Trial

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks [ Time Frame: At baseline and 12 weeks ]
    The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1="none", 2="mild", 3="moderate", 4="severe" and 5="very severe" to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline).


Enrollment: 464
Study Start Date: July 2011
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I low dose DHEA
Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Drug: prasterone
Applied vaginally
Experimental: Arm II high dose DHEA
Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Drug: prasterone
Applied vaginally
Placebo Comparator: Arm III placebo
Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Other: placebo
Applied vaginally

Detailed Description:

Primary Goal:

  • To determine the effectiveness of two doses of daily vaginal prasterone (dehydroepiandrosterone [DHEA]) versus placebo for alleviation of the most bothersome vaginal symptom (vaginal dryness or dyspareunia) over 12 weeks.

Exploratory Goals:

  • To evaluate any toxicities arising from DHEA in this patient population. (Exploratory)
  • To evaluate the impact of vaginal DHEA on negative sexual thoughts, sexual function and urologic symptoms. (Exploratory)
  • To explore the role of psychologic (mood, stress), physical (demographics and treatment variables) and situational factors (partner variables and fatigue) as predictors of vaginal dryness and performance outcomes at baseline and at various endpoints throughout the study. (Exploratory)
  • To explore the characteristics of vaginal atrophy and the relationship between vaginal atrophy and quality-of-life questionnaire responses and exposure to hormonal therapy (tamoxifen, exemestane, anastrozole, or letrozole). (Exploratory)
  • To examine the effects of the use of open-label vaginal DHEA gel over 8 weeks in women completing the placebo gel arm of the randomized trial. (Exploratory)

Correlative Research Goals:

  • To evaluate the impact of vaginal DHEA on maturation index and pH (select institutions).
  • To evaluate the impact of vaginal DHEA on sex steroid concentrations (estradiol, free testosterone, estrone, and DHEA-S) and markers of bone turnover (osteocalcin and bone alkaline phosphatase). (Correlative)
  • As part of ongoing research for NCCTG Cancer Control studies, we are banking blood products for future studies. (Correlative)

OUTLINE: This is a multicenter study. Patients are stratified according to current tamoxifen therapy (yes vs no), concurrent aromatase inhibitor use (anastrozole/letrozole vs exemestane vs none), hysterectomy (yes vs no), and cigarette smoking (current vs past vs never). Patients are randomized to 1 of 3 treatment arms, patients receive low dose vaginal DHEA, high dose vaginal DHEA or vaginal placebo gel.

Participants may complete the Profile of Mood States (POMS), the Perceived Stress Scale (PSS), the Fatigue: Vitality subscale of the SF-36, the Vaginal Symptom Quality Questionnaire, the DHEA Side Effect Questionnaire, the Female Sexual Function Index (FSFI), the Sexually Related Intrusive Thoughts - ITS, Impact of Treatment Scale, the Urogenital Atrophy Questionnaire, and the Subject Global Impression of Change at baseline and periodically during study.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Postmenopausal women with a history of breast or gynecologic cancer (currently no evidence of disease). Note: Postmenopausal status will be determined by the following criteria:

    1. 12 months without a period or bilateral oophorectomy or complete chemical ovarian suppression for the past 12 months with continued suppression planned throughout the course of the study
    2. menopausal status will be determined by an FSH and an estradiol value in the postmenopausal range (generally FSH > 40IU/L and estradiol < 10 pg/ml, depending on laboratory) if:

      • 9 months without a period or
      • post hysterectomy with at least one ovary remaining and less than 55 years old. Note: if age 55 or older with these criteria, then menopausal status does not need to be determined by labs
  3. Significant vaginal complaints. Note: Defined as persistent vaginal dryness and/or pain with intercourse (dyspareunia) of sufficient severity to make a patient desire therapeutic intervention.
  4. Eligibility questionnaire response must be moderate or worse levels of severity on one of the two symptoms, either dryness or dyspareunia. The protocol contains more information.
  5. Vaginal symptoms must have been present ≥ 2 months prior to randomization.
  6. Life expectancy > 12 months.
  7. Ability to complete questionnaires by themselves or with assistance.
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
  9. The patient must provide informed written consent.
  10. Willing to return to the enrolling institution for follow-up.
  11. Willing to provide blood samples for correlative research purposes.

Exclusion Criteria:

  1. Initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months prior to randomization or plans to initiate or discontinue any of these medications during the 12-week study.
  2. Current diagnosis of an active vaginal infection, if symptoms of vaginal infection, this must be ruled out (ie, foul discharge, fever).
  3. Concurrent chemotherapy (long term adjuvant herceptin, lapatanib, and/or bevacizumab is allowed.
  4. Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations). Note: Water-based lubricants (such as KY jelly) are allowed during sexual intercourse.
  5. Use of any daily non-hormonal vaginal preparations ≤ 1 week prior to study entry.

    Exception: Daily water-based lubricants for sexual intercourse. Note: Patients who stop agent may be enrolled after one week.

  6. Current (≤ 4 weeks prior to randomization), or planned during the study period, use of any estrogen product or any kind of hormonal vaginal product including bioidentical hormones, estriol or any androgen product.
  7. Use of pharmacologic soy or phytoestrogen preparations (Dietary intake of soy - ie milk is acceptable).
  8. On a placebo controlled trial for endocrine therapy.
  9. Prior or concurrent pelvic radiation therapy.
  10. Prior radical pelvic surgery, specifically vaginectomy or pelvic exenteration (TAH/BSO) is allowed).
  11. Diagnosis of any of the following conditions within the past five years:

    1. Essential vulvodynia
    2. Vulvar vestibulitis
    3. Bartholin cyst/abscess
    4. History of Bartholin gland surgery
    5. Lichen sclerosis
    6. Lichen planus of the vulvovaginal region
    7. Desquamative vaginitis
  12. History or current diagnosis of any of the following conditions:

    1. Vulvar or vaginal dysplasia
    2. Vaginal prolapse
  13. Women of childbearing potential, premenopausal women.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376349


  Show 280 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Mayo Clinic
Investigators
Principal Investigator: Debra Barton, RN, PhD, AOCN, FAAN University of Michigan
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01376349     History of Changes
Other Study ID Numbers: NCCTG-N10C1
CDR0000702003 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-02677 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: June 17, 2011
First Posted: June 20, 2011
Results First Submitted: December 8, 2016
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017
Last Verified: July 2017

Keywords provided by Alliance for Clinical Trials in Oncology:
cancer survivor
breast cancer
cervical cancer
fallopian tube cancer
vaginal cancer
vulvar cancer
ovarian epithelial cancer
ovarian germ cell tumor
ovarian stromal cancer
primary peritoneal cavity cancer
endometrial cancer
depression
anxiety disorder
cognitive/functional effects
sexual dysfunction
uterine sarcoma
ovarian sarcoma

Additional relevant MeSH terms:
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs