Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

NCT02013544 | Completed Phase 3 Results

• 1 other identifier: ERC-238
• Study Type: interventional
• Target: 558
• Locations: 2 countries
• Sites: 38

Brief Summary

The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.

Conditions

Vaginal Atrophy

Keywords

Vulvovaginal atrophy (VVA); Vaginal atrophy; Atrophic vaginitis; prasterone; DHEA; Intrarosa

Outcome Measures

Primary Outcomes (4)

• Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear

  The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

  Baseline and Week 12

• Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear

  The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

  Baseline and Week 12

• Change From Baseline to Week 12 in Vaginal pH

  A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

  Baseline and Week 12

• Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia

  The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

  Baseline and Week 12

Secondary Outcomes (5)

• Change From Baseline to Week 12 in Severity of Vaginal Dryness

  Baseline and Week 12

• Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions

  Baseline and Week 12

• Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity

  Baseline and Week 12

• Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness

  Baseline and Week 12

• Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color

  Baseline and Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo vaginal ovule daily for 12 weeks

Drug: Placebo

Prasterone

EXPERIMENTAL

Prasterone (DHEA) vaginal ovule daily for 12 weeks

Drug: Prasterone (DHEA)

Interventions

Placebo DRUG

Placebo

Prasterone (DHEA) DRUG

Prasterone

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Main criteria:
• Postmenopausal women (hysterectomized or not)
• Women between 40 and 80 years of age
• Women having ≤5% of superficial cells on vaginal smear at baseline
• Women having a vaginal pH above 5 at baseline
• Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
• Willing to participate in the study and sign an informed consent

You may not qualify if:

• Main criteria:
• Previous enrollment in EndoCeutics studies performed with intravaginal DHEA
• Previous diagnosis of cancer, except skin cancer (non melanoma)
• Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
• The administration of any investigational drug within 30 days of screening visit
• Clinically significant abnormal serum biochemistry, urinalysis or hematology

Sponsors & Collaborators

• EndoCeutics Inc.: lead

Study Sites (38)

EndoCeutics site # 39

Montgomery, Alabama, 36117, United States

Location

EndoCeutics site # 14

Tucson, Arizona, 85712, United States

Location

EndoCeutics site # 21

Sacramento, California, 95821, United States

Location

EndoCeutics site # 83

San Diego, California, 92103, United States

Location

EndoCeutics site # 30

San Diego, California, 92108, United States

Location

EndoCeutics site # 36

Denver, Colorado, 80209, United States

Location

EndoCeutics site # 52

Denver, Colorado, 80220, United States

Location

EndoCeutics site # 45

Boynton Beach, Florida, 33472, United States

Location

EndoCeutics site # 60

Lake Worth, Florida, 33461, United States

Location

EndoCeutics site # 54

North Miami, Florida, 33161, United States

Location

EndoCeutics site # 80

West Palm Beach, Florida, 33409, United States

Location

EndoCeutics site # 23

Atlanta, Georgia, 30328, United States

Location

EndoCeutics site # 55

Wichita, Kansas, 67226, United States

Location

EndoCeutics site # 86

Louisville, Kentucky, 40291, United States

Location

EndoCeutics site # 27

Lutherville, Maryland, 21093, United States

Location

EndoCeutics site # 87

Lawrenceville, New Jersey, 08648, United States

Location

EndoCeutics site # 81

Plainsboro, New Jersey, 08536, United States

Location

EndoCeutics site # 05

Cleveland, Ohio, 44122, United States

Location

EndoCeutics site # 15

Columbus, Ohio, 43213, United States

Location

EndoCeutics site # 75

Philadelphia, Pennsylvania, 19114-1029, United States

Location

EndoCeutics site # 84

Corpus Christi, Texas, 78414, United States

Location

EndoCeutics site # 82

Houston, Texas, 77030, United States

Location

EndoCeutics site # 03

Norfolk, Virginia, 23507, United States

Location

EndoCeutics site # 76

Seattle, Washington, 98105, United States

Location

EndoCeutics site # 85

Burlington, Ontario, L7R 4B8, Canada

Location

EndoCeutics site # 69

Corunna, Ontario, N0N1G0, Canada

Location

EndoCeutics site # 68

Sarnia, Ontario, N7T 4X3, Canada

Location

EndoCeutics site # 73

Waterloo, Ontario, N2J 1C4, Canada

Location

EndoCeutics site # 04

Drummondville, Quebec, J2B 7T1, Canada

Location

EndoCeutics site # 12

Montreal, Quebec, H4N 3C5, Canada

Location

EndoCeutics site # 79

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

EndoCeutics site # 02

Québec, Quebec, G1S 2L6, Canada

Location

EndoCeutics site # 01

Québec, Quebec, G1V 2L9, Canada

Location

EndoCeutics site # 77

Québec, Quebec, G1W 4R4, Canada

Location

EndoCeutics site # 78

Québec, Quebec, G3K 2P8, Canada

Location

EndoCeutics site # 18

Saint Romuald, Quebec, G6W 5M6, Canada

Location

EndoCeutics site # 74

Sherbrooke, Quebec, J1J 2G2, Canada

Location

EndoCeutics site # 67

Victoriaville, Quebec, G6P 6P6, Canada

Location

Related Publications (6)

• Ke Y, Labrie F, Gonthier R, Simard JN, Bergeron D, Martel C, Vaillancourt M, Montesino M, Lavoie L, Archer DF, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration. J Steroid Biochem Mol Biol. 2015 Nov;154:186-96. doi: 10.1016/j.jsbmb.2015.08.016. Epub 2015 Aug 17.

  PMID: 26291918 RESULT

• Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.

  PMID: 26597311 RESULT

• Labrie F, Montesino M, Archer DF, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner. Climacteric. 2015;18(6):817-25. doi: 10.3109/13697137.2015.1077508. Epub 2015 Oct 30.

  PMID: 26517756 RESULT

• Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.

  PMID: 26731686 RESULT

• Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur E; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016 May;159:142-53. doi: 10.1016/j.jsbmb.2016.03.016. Epub 2016 Mar 10.

  PMID: 26972555 RESULT

• Montesino M, Labrie F, Archer DF, Zerhouni J, Cote I, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Moyneur E, Balser J. Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator. Gynecol Endocrinol. 2016;32(3):240-5. doi: 10.3109/09513590.2015.1110140. Epub 2016 Jan 6.

  PMID: 26634942 RESULT

MeSH Terms

Conditions

Atrophic Vaginitis

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Results Point of Contact

• Title: Director of Data Analysis
• Organization: Endoceutics

celine.martel@endoceutics.com

418-653-0033

Study Officials

• Fernand Labrie, M.D., Ph.D.

  EndoCeutics Inc.

  STUDY CHAIR

• David F Archer, M.D.

  Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 17, 2013
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 1, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-05

Locations

CA (14); US (24)