Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study

Hypoactive Sexual Desire Disorder (HSDD) Clinical Trial

Official title:

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study (Placebo-Controlled, Double-Blind and Randomized Phase III Study of Intravaginal Prasterone)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03619005
• Other study ID #: ERC-245
• Status: Withdrawn
• Phase: Phase 3
• Start date: November 13, 2018
• Est. completion date: December 6, 2019

Study information

• Verified date: July 2020
• Source: EndoCeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 6, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria (main criteria):

• Postmenopausal women (hysterectomized or not).

• Women between 40 and 80 years of age.

• Being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months.

• Diagnosis of HSDD confirmed by a qualified clinician.

• Willing to participate in the study and sign an informed consent.

Exclusion Criteria (main criteria):

• Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity.

• Taking drugs which could be responsible for HSDD.

• Severe medical condition which can explain the loss of sexual desire.

• The administration of any investigational drug within 30 days of screening visit.

• Clinically significant abnormal serum biochemistry, urinalysis or hematology.

Related Conditions & MeSH terms

• Disease
• Hypoactive Sexual Desire Disorder (HSDD)
• Hypokinesia
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Placebo Vaginal Insert
Daily administration of a placebo vaginal insert.
• Prasterone 6.5 mg (0.50%) Vaginal Insert
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.

Locations

Country	Name	City	State
United States	Endoceutics site # 127	Bluffton	South Carolina
United States	Endoceutics site # 115	Fargo	North Dakota
United States	Endoceutics site # 106	Huntsville	Alabama
United States	Endoceutics site # 125	New London	Connecticut
United States	Endoceutics site # 20	New York	New York
United States	Endoceutics site # 119	Roswell	Georgia
United States	Endoceutics site # 114	Saint Petersburg	Florida
United States	Endoceutics site # 102	San Antonio	Texas
United States	Endoceutics site # 17	San Diego	California
United States	Endoceutics site # 91	Savannah	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
EndoCeutics Inc.	AMAG Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Côté 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. — View Citation

Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009 Sep-Oct;16(5):923-31. doi: 10.1097/gme.0b013e31819e85c6. — View Citation

Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Côté I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur É; 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual desire	Change from Baseline in sexual desire as evaluated by Questions 1 & 2 of the 19-items questionnaire titled Female Sexual Function Index (FSFI). For this outcome, Question 1 and Question 2 (corresponding to the desire domain) will be graded from 1 to 5 (score range) and then be multiplied by 0.6 (domain factor). The desire domain (sum of scores from Questions 1 & 2) has a minimum score of 1.2 and a maximum score of 6. Higher values represent a better outcome.	28 weeks
Primary	Distress from low sexual desire	Change from Baseline in distress from low sexual desire as evaluated by Question 13 of the 15-items questionnaire titled Female Sexual Distress Scale - Desire Arousal Orgasm (FSDS-DAO). For this outcome, Question 13 is graded from 0 to 4 and a lower value represents a better outcome.	28 weeks
Secondary	Satisfying sexual events (SSEs)	Change from Baseline in the number of SSEs from a daily log of sexual activity.	28 weeks