DHEA Against Vaginal Atrophy - Safety Study of 12 Months

NCT01256671 | Completed Phase 3 Results DMC

• 1 other identifier: ERC-230
• Study Type: interventional
• Target: 530
• Locations: 2 countries
• Sites: 41

Brief Summary

The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.

Conditions

Vaginal Atrophy

Keywords

Vulvar/Vaginal Atrophy; Atrophic Vaginitis; Dehydroepiandrosterone; DHEA; Prasterone; Vaginorm; Menopause; Intrarosa

Outcome Measures

Primary Outcomes (2)

• Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium

  The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.

  Baseline and Week 52 (or discontinuation)

• Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels

  The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.

  Baseline and Week 52

Secondary Outcomes (6)

• Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells).

  Baseline and Week 52

• Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells).

  Baseline and Week 52

• Change From Baseline to Week 52 of Vaginal pH.

  Baseline and Week 52

• Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia

  Baseline and Week 52

• Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness

  Baseline and Week 52

Study Arms (1)

DHEA

EXPERIMENTAL

0.5% DHEA (intravaginal)

Drug: DHEA

Interventions

DHEA DRUG

Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.

Also known as: Prasterone, Dehydroepiandrosterone, Vaginorm

DHEA

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women (non-hysterectomized)
• Women between 40 and 75 years of age.
• Willing to participate in the study and sign an informed consent.
• Women who have self-identified symptom(s) of vaginal atrophy.
• Willing to have endometrial biopsy at screening and end of study (Week 52).

You may not qualify if:

• Undiagnosed abnormal genital bleeding.
• Hypertension equal to or above 140/90 mm Hg.
• The administration of any investigational drug within 30 days of screening visit.
• Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.

Sponsors & Collaborators

• EndoCeutics Inc.: lead

Study Sites (41)

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 # 30

San Diego, California, 92108, United States

Location

EndoCeutics site # 17

San Diego, California, 92120, United States

Location

EndoCeutics site # 36

Denver, Colorado, 80218, United States

Location

EndoCeutics site # 42

Milford, Connecticut, 06460, United States

Location

EndoCeutics site # 07

Washington D.C., District of Columbia, 20036, United States

Location

EndoCeutics site # 45

Boynton Beach, Florida, 33472, United States

Location

EndoCeutics site # 26

Jacksonville, Florida, 32207, United States

Location

EndoCeutics site # 41

West Palm Beach, Florida, 33401, United States

Location

EndoCeutics site # 23

Sandy Springs, Georgia, 30328, United States

Location

EndoCeutics site # 10

Meridian, Idaho, 83642, United States

Location

EndoCeutics site # 27

Baltimore, Maryland, 21285-6815, United States

Location

EndoCeutics site # 22

Kalamazoo, Michigan, 49009, United States

Location

EndoCeutics site # 25

Lincoln, Nebraska, 68510, United States

Location

EndoCeutics site # 24

Omaha, Nebraska, 68131, United States

Location

EndoCeutics site # 28

Moorestown, New Jersey, 08057, United States

Location

EndoCeutics site # 50

Neptune City, New Jersey, 07753, United States

Location

EndoCeutics site # 44

New Brunswick, New Jersey, 08901, United States

Location

EndoCeutics site # 19

New York, New York, 10016, United States

Location

EndoCeutics site # 16

Durham, North Carolina, 27713, United States

Location

EndoCeutics site # 33

Beachwood, Ohio, 44122, United States

Location

EndoCeutics site # 05

Cleveland, Ohio, 44122, United States

Location

EndoCeutics site # 47

Cleveland, Ohio, 44124, United States

Location

EndoCeutics site # 15

Columbus, Ohio, 43213, United States

Location

EndoCeutics site # 35

Pittsburgh, Pennsylvania, 15206, United States

Location

EndoCeutics site # 09

West Jordan, Utah, 84088, United States

Location

EndoCeutics site # 31

Charlottesville, Virginia, 22903, United States

Location

EndoCeutics site # 03

Norfolk, Virginia, 23507, United States

Location

EndoCeutics site # 38

Renton, Washington, 98055, United States

Location

EndoCeutics site # 13

Calgary, Alberta, T2N 4L7, Canada

Location

EndoCeutics site # 06

Bathurst, New Brunswick, E2A 4X7, Canada

Location

EndoCeutics site # 04

Drummondville, Quebec, J2B 7T1, Canada

Location

EndoCeutics site # 34

Montreal, Quebec, H2X 3J4, Canada

Location

EndoCeutics site # 12

Montreal, Quebec, H4N 3C5, Canada

Location

EndoCeutics site # 02

Québec, Quebec, G1S 2L6, Canada

Location

EndoCeutics site # 01

Québec, Quebec, G1V 2L9, Canada

Location

EndoCeutics site # 18

Saint Romuald, Quebec, G6W 5M6, Canada

Location

EndoCeutics site # 08

Shawinigan, Quebec, G9N 2H6, Canada

Location

EndoCeutics site # 11

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Related Publications (5)

• Labrie F, Archer DF, Bouchard C, Girard G, Ayotte N, Gallagher JC, Cusan L, Baron M, Blouin F, Waldbaum AS, Koltun W, Portman DJ, Cote I, Lavoie L, Beauregard A, Labrie C, Martel C, Balser J, Moyneur E; Members of the VVA Prasterone Group. Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study. Maturitas. 2015 May;81(1):46-56. doi: 10.1016/j.maturitas.2015.02.005. Epub 2015 Feb 16.

  PMID: 25771041 RESULT

• Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.

  PMID: 26725467 RESULT

• Ke Y, Gonthier R, Simard JN, Archer D, Lavoie L, Martel C, Vaillancourt M, Labrie F. Serum steroids remain within the same normal postmenopausal values during 12-month intravaginal 0.50% DHEA. Horm Mol Biol Clin Investig. 2015 Dec;24(3):117-29. doi: 10.1515/hmbci-2015-0035.

  PMID: 26509785 RESULT

• Portman DJ, Labrie F, Archer DF, Bouchard C, Cusan L, Girard G, Ayotte N, Koltun W, Blouin F, Young D, Wade A, Martel C, Dube R; other participating members of VVA Prasterone Group. Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women. Menopause. 2015 Dec;22(12):1289-95. doi: 10.1097/GME.0000000000000470.

  PMID: 25968836 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

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

• David F Archer, MD

  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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 8, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 18, 2017
• Results First Posted: October 18, 2017

Record last verified: 2017-09

Locations

CA (10); US (31)