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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01376349
First received: June 17, 2011
Last updated: February 24, 2013
Last verified: February 2013
  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
Cancer
Drug: prasterone
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Alleviation of the most bothersome vaginal symptom (vaginal dryness or dyspareunia) over 12 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of vaginal DHEA on maturation index and pH [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]

Estimated Enrollment: 456
Study Start Date: July 2011
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Participants apply a low dose of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks.
Drug: prasterone
Applied vaginally
Experimental: Arm II
Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks.
Drug: prasterone
Applied vaginally
Placebo Comparator: Arm III
Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.
Other: placebo
Applied vaginally

Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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)
  • To evaluate the impact of vaginal DHEA on maturation index and pH (select institutions). (Correlative)
  • 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)
  • To bank 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 (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.

  • Arm I: Participants apply a low dose of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks.
  • Arm II: Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks.
  • Arm III: Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.

    • Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks.

Participants undergo blood sample collection at baseline and during weeks 11-12 for estradiol, free testosterone, estrone, DHEA-sulfate, osteocalcin, and bone alkaline phosphatase analysis. Some participants also undergo vaginal cells collection and vaginal pH tests.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Postmenopausal women with a history of breast or gynecologic cancer (currently no evidence of disease)

    • Postmenopausal status determined by the following criteria:

      • 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
      • FSH and an estradiol value in the postmenopausal range (generally FSH >40 IU/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
      • For age 55 or older, menopausal status does not need to be determined by laboratory exams
  • Significant vaginal complaints defined as persistent vaginal dryness and/or pain with intercourse (dyspareunia) of sufficient severity to make a patient desire therapeutic intervention
  • Eligibility questionnaire response must be moderate or worse levels of severity on one of the two symptoms, either dryness or dyspareunia
  • Vaginal symptoms must have been present ≥ 2 months prior to randomization

PATIENT CHARACTERISTICS:

  • Life expectancy > 12 months
  • ECOG performance status 0 or 1
  • Ability to complete questionnaires by themselves or with assistance
  • Willing to return to NCCTG enrolling institution for follow-up
  • Willing to provide blood samples for correlative research purposes
  • Willing to undergo brief pelvic exam at baseline and week 11-12, if institution participating in that portion of the study
  • No current diagnosis of an active vaginal infection; if symptoms of vaginal infection (i.e., foul discharge, fever) present, then infection must be ruled out
  • No diagnosis of any of the following conditions within the past five years:

    • Essential vulvodynia
    • Vulvar vestibulitis
    • Bartholin cyst/abscess
    • History of Bartholin gland surgery
    • Lichen sclerosis
    • Lichen planus of the vulvovaginal region
    • Desquamative vaginitis
  • No history or current diagnosis of any of the following conditions (ever):

    • Vulvar or vaginal dysplasia
    • Vaginal prolapse
  • No women of childbearing potential or premenopausal women

PRIOR CONCURRENT THERAPY:

  • No initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months prior to randomization or plan to initiate or discontinue any of these medications during the 12-week study
  • No concurrent chemotherapy

    • Long-term adjuvant trastuzumab, lapatinib, and/or bevacizumab is allowed
  • Not planning to use any vaginal preparations during the study period (including any over-the-counter or herbal preparations)

    • Water-based lubricants, such as KY jelly, are allowed during sexual intercourse
  • No use of any daily non-hormonal vaginal preparations ≤ 1 week prior to study entry

    • Patients who stop agent may be enrolled after 1 week
  • More then 4 weeks since prior and no concurrent use of any estrogen product or any kind of hormonal vaginal product including bio-identical hormones, estriol, or any androgen product
  • No concurrent pharmacologic soy or phytoestrogen preparations (dietary intake of soy [i.e., soy milk] is acceptable)
  • Not on a placebo-controlled trial for endocrine therapy
  • No prior or concurrent pelvic radiotherapy
  • No prior radical pelvic surgery, specifically vaginectomy or pelvic exenteration

    • Prior total abdominal hysterectomy (TAH) and/or bilateral salpingo-oophorectomy (BSO) allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376349

  Show 280 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Debra Barton, RN, PhD, AOCN, FAAN Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Jan C. Buckner, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT01376349     History of Changes
Other Study ID Numbers: CDR0000702003, NCCTG-N10C1
Study First Received: June 17, 2011
Last Updated: February 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
depression
anxiety disorder
cognitive/functional effects
sexual dysfunction
cancer survivor
breast cancer
cervical cancer
fallopian tube cancer
uterine sarcoma
vaginal cancer
vulvar cancer
ovarian epithelial cancer
ovarian germ cell tumor
ovarian sarcoma
ovarian stromal cancer
primary peritoneal cavity cancer
endometrial cancer

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

ClinicalTrials.gov processed this record on April 17, 2014