Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder

Hypoactive Sexual Desire Disorder Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Investigate the Safety and Efficacy of Lybridos in the Domestic Setting in Healthy Female Subjects With Hypoactive Sexual Desire Disorder and Maladaptive Activity of Sexual Inhibitory Mechanisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101203
• Other study ID #: EB90a extension
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2014
• Last updated: March 23, 2015
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2014
• Source: Emotional Brain NY Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.

This is a 2-arm placebo and Lybridos (0.5 mg testosterone + buspirone 10 mg) extension to study EB90 (Clinical Study Protocol EB90a, version 3.0, 07 June 2013).

In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s). Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours after each sexual activity. The following hypotheses will be tested:

Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual events.

Objectives:

To investigate the efficacy of Lybridos as compared to placebo in increasing the number of satisfactory sexual episodes in healthy female subjects with hypoactive sexual desire disorder (HSDD) and maladaptive activity of sexual inhibitory mechanisms

• To identify the optimal dose of Lybridos to take into phase 3 clinical development

• To confirm that Lybridos has superior efficacy as compared to testosterone alone and to buspirone alone

• To evaluate the effect of Lybridos as measured by scales of sexual satisfaction and/or sexual desire/arousal

• To evaluate the safety profile of Lybridos

Description:

None entered

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

Subjects must meet all of the following criteria:

1. Provision of written informed consent

2. Females between 21 and 70 years of age, inclusive, pre or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder [FSAD] and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained health care professional.

3. Maladaptive activity of sexual inhibitory mechanism(s) (see appendix 4 for definition)

4. Be involved in a stable relationship and have a partner who will be at home for the majority of the study duration

5. Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

Subjects who meet any of the following criteria are not eligible to participate in the study:

Cardiovascular Conditions

1. Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity

2. Systolic blood pressure = 140 mmHg and/or diastolic blood pressure > 90 mmHg. For subjects = 60 years old and without diabetes mellitus, familial hypercholesterolemia, or cardiovascular disease: systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 90 mmHg

3. Systolic blood pressure = 90 mmHg and/or diastolic blood pressure = 50 mmHg Gynecological and Obstetric Conditions

4. Use of any contraceptive containing anti-androgens (e.g. Cyproteron acetate) or (anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel)

5. Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 µg/day of estrogen

6. Positive test result for Chlamydia or gonorrhea

7. Pregnancy or intention to become pregnant during this study (Note: A urine pregnancy test will be performed in all women of child bearing potential prior to the administration of study medications.)

8. Lactating or delivery in the previous 6 months prior to signing Informed Consent Form

9. Significant abnormal Pap smear in the previous 12 months prior to signing Informed Consent Form

10. History of bilateral oophorectomy

11. Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns

12. Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms (e.g. hot flashes, night sweating) in combination with elevated FSH levels (>40 IU/L) for women from age 40 onwards; in women with a history of hysterectomy perimenopausality can be assessed by FSH levels (>40 IU/L) and/or vasomotor symptoms Other Medical Conditions

13. Liver and/or renal insufficiency (aspartate aminotransferase, alanine aminotransferase and gamma glutamyltransferase > 3 times the upper limit of normal and/or estimated glomerular filtration rate (eGFR) < 60.00 mL/min based on the Cockcroft Gault formula)

14. Any current endocrine disease or endocrinopathy (e.g. uncontrolled thyroid dysfunction) as determined by medical history, basic physical examination and/or laboratory values significantly outside the normal range of the central laboratory; or uncontrolled diabetes mellitus(HbA1c > 7.5%)

15. Free- and/or total testosterone levels outside the upper limit of the reference range of the central laboratory (free testosterone: > 1.1 ng/dL, and total testosterone > 80 ng/dL)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Placebo

• 0.5 mgTestosterone + 10 mg Buspirone
A total of 28 doses will be provided. Subjects are required to take a minimum of 8 doses over the 8-week treatment period (1 dose/week). The other 20 doses may be taken as desired (ie, "on demand") throughout the 8-week treatment period; dosing is permitted every 2 days (ie, on alternate days).

Locations

Country	Name	City	State
United States	Annapolis Sexual Wellness Center	Annapolis	Maryland
United States	Meridien Research	Bradenton	Florida
United States	NECCR Fall River LLC	Fall River	Massachusetts
United States	Maryland Center for Sexual Wellness	Lutherville	Maryland
United States	Compass Research	Orlando	Florida
United States	Philadelphia Clinical Research, LLC	Philadelphia	Pennsylvania
United States	Maryland Primary Care Physicians	Queenstown	Maryland
United States	San Diego Sexual Medicine	San Diego	California
United States	Meridien Research	St. Petersburg	Florida
United States	Comprehensive Clinical Trials LLC	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Emotional Brain NY Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the number of satisfactory sexual episodes, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ).	Sexual satisfaction will be evaluated based on a global satisfaction assessment comparing the 4-week establishment period with the 8 week DB treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks.	20 weeks	No
Secondary	Sexual Satisfaction	Sexual satisfaction will be evaluated based on a global satisfaction assessment comparing the 4-week establishment period with the 8 week DB treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks	20 weeks	No
Secondary	Sexual desire and arousal	Sexual desire and arousal will be evaluated based on the 'desire' and 'arousal' domains of the Sexual Anamnesis Questionnaire, the Sexual Function questionnaire and weekly diaries throughout the course of the study.	20 weeks	No
Secondary	Sexual Distress	Sexual Distress will be assessed using the Female Sexual Distress Scale-Revised (FSDS-R).	20 weeks	No
Secondary	Subjective evaluation of gain and improvement	Using the following tools, perceived gain and improvement will be assessed: Subjective Evaluation of Gain (SEG); Subjective Evaluation of Improvement (SEI); Patient's Global Impression of Improvement (PGI-I); Patient Benefit Evaluation (PBE)	20 weeks	No