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.

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.

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.

Arm I Low Dose DHEA

Arm II High Dose DHEA

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.

Arm III Placebo

Total

Sex: Female, Male

Region of Enrollment

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).

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.

Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks

Raondomized Treatment

Optional Continuation Phase

Debra Barton, R.N., Ph.D.

Arm I: Low Dose DHEA

Arm II: High Dose DHEA

Arm III: Placebo

Patients randomized to Arm III Placebo who have completed protocol treatment for 12 weeks were offered the option of continuing treatment according to Arm II High Dose DHEA until unacceptable adverse events or patient refusal to continue participation on the study.
94 of the 147 patients randomized to the Placebo arm opted to continue treatment with High Dose DHEA.

Breast Cancer

Gynecologic Cancer

prasterone

placebo

Mayo Clinic Scottsdale

Aurora Presbyterian Hospital

Boulder Community Hospital

Penrose Cancer Center at Penrose Hospital

St. Anthony Central Hospital

Porter Adventist Hospital

Presbyterian - St. Luke's Medical Center

St. Joseph Hospital

Rose Medical Center

CCOP - Colorado Cancer Research Program

Swedish Medical Center

Poudre Valley Hospital

Front Range Cancer Specialists

North Colorado Medical Center

Littleton Adventist Hospital

Sky Ridge Medical Center

Hope Cancer Care Center at Longmont United Hospital

McKee Medical Center

Parker Adventist Hospital

St. Mary - Corwin Regional Medical Center

North Suburban Medical Center

Exempla Lutheran Medical Center

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Herbert D. Kerman Regional Oncology Center - Daytona Beach

University of Florida Shands Cancer Center

Mayo Clinic - Jacksonville

Kapiolani Medical Center at Pali Momi

Cancer Research Center of Hawaii

OnCare Hawaii, Incorporated - Lusitana

Queen's Cancer Institute at Queen's Medical Center

Straub Clinic and Hospital, Incorporated

Hawaii Medical Center - East

OnCare Hawaii, Incorporated - Kuakini

Kapiolani Medical Center for Women and Children

Castle Medical Center

Kauai Medical Clinic

Maui Memorial Medical Center

Pacific Cancer Institute - Maui

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Idaho Urologic Institute, PA

Illinois CancerCare - Bloomington

St. Joseph Medical Center

Illinois CancerCare - Canton

Illinois CancerCare - Carthage

Eureka Community Hospital

Illinois CancerCare - Eureka

Galesburg Clinic, PC

Illinois CancerCare - Havana

Illinois CancerCare - Kewanee Clinic

Illinois CancerCare - Macomb

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Illinois CancerCare - Monmouth

OSF Holy Family Medical Center

BroMenn Regional Medical Center

Community Cancer Center

Illinois CancerCare - Community Cancer Center

Community Hospital of Ottawa

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Cancer Treatment Center at Pekin Hospital

Illinois CancerCare - Pekin

Proctor Hospital

CCOP - Illinois Oncology Research Association

Oncology Hematology Associates of Central Illinois, PC - Peoria

Methodist Medical Center of Illinois

OSF St. Francis Medical Center

Illinois CancerCare - Peru

Illinois Valley Community Hospital

Illinois CancerCare - Princeton

Illinois CancerCare - Spring Valley

CCOP - Carle Cancer Center

Elkhart Clinic, LLC

Michiana Hematology-Oncology, PC - Elkhart

Elkhart General Hospital

St. Francis Hospital Cancer Care Services

Howard Community Hospital

Center for Cancer Therapy at LaPorte Hospital and Health Services

Saint Anthony Memorial Health Centers

Michiana Hematology-Oncology, PC - South Bend

Saint Joseph Regional Medical Center

Michiana Hematology Oncology PC - Plymouth

Reid Hospital & Health Care Services

CCOP - Northern Indiana CR Consortium

Memorial Hospital of South Bend

Michiana Hematology Oncology PC - La Porte

Cedar Rapids Oncology Associates

Mercy Regional Cancer Center at Mercy Medical Center

Medical Oncology and Hematology Associates - West Des Moines

Mercy Cancer Center - West Lakes

CCOP - Iowa Oncology Research Association

John Stoddard Cancer Center at Iowa Methodist Medical Center

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Medical Oncology and Hematology Associates at Mercy Cancer Center

Mercy Cancer Center at Mercy Medical Center - Des Moines

John Stoddard Cancer Center at Iowa Lutheran Hospital

Siouxland Hematology-Oncology Associates, LLP

Mercy Medical Center - Sioux City

St. Luke's Regional Medical Center

Methodist West Hospital

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

Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo- Controlled Trial

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Mayo Clinic

Early Pregnancy

University of Michigan

NIEHS, Research Triangle Park

Influence of Social and Environmental Factors on Women's Reproductive Function in a Maya Community of Guatemala

The Influence of Social and Environmental Factors on Fecundability in a Maya Community of Guatemala

National Institute of Environmental Health Sciences (NIEHS)

estrone

atrophy

estrone/atrophy

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

Influence of Social and Environmental Factors on Women's Reproductive Function in a Maya Community of Guatemala

Baz done ki pi konplè remèd fèy medsin te apiye nan syans