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

Sponsor

EndoCeutics Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03619005

Collaborator

AMAG Pharmaceuticals, Inc. (Industry)

Enrollment

Locations

Arms

12.7

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypoactive Sexual Desire Disorder (HSDD)	Drug: Placebo Vaginal Insert Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Nov 13, 2018

Actual Primary Completion Date :

Aug 15, 2019

Actual Study Completion Date :

Dec 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo Vaginal Insert Daily administration of a placebo vaginal insert.
Active Comparator: Prasterone	Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: Placebo Vaginal Insert

Daily administration of a placebo vaginal insert.

Active Comparator: Prasterone

Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert

Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.

Outcome Measures

Primary Outcome Measures

Sexual desire [28 weeks]
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.
Distress from low sexual desire [28 weeks]
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.

Secondary Outcome Measures

Satisfying sexual events (SSEs) [28 weeks]
Change from Baseline in the number of SSEs from a daily log of sexual activity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endoceutics site # 106	Huntsville	Alabama	United States	35801
2	Endoceutics site # 17	San Diego	California	United States	92120
3	Endoceutics site # 125	New London	Connecticut	United States	06320
4	Endoceutics site # 114	Saint Petersburg	Florida	United States	33709
5	Endoceutics site # 119	Roswell	Georgia	United States	30075
6	Endoceutics site # 91	Savannah	Georgia	United States	31406
7	Endoceutics site # 20	New York	New York	United States	10016
8	Endoceutics site # 115	Fargo	North Dakota	United States	58103
9	Endoceutics site # 127	Bluffton	South Carolina	United States	29910
10	Endoceutics site # 102	San Antonio	Texas	United States	78229