Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder

NCT01607658 | Completed Phase 2 Results

• 1 other identifier: TBS-2-AMB-2012-01
• Study Type: interventional
• Target: 253
• Locations: 3 countries
• Sites: 53

Brief Summary

The purpose of this study is to assess and compare the effects of 3 dose strengths of TBS-2 intranasal testosterone gel to placebo on the occurrence of orgasm.

Conditions

Female Orgasmic Disorder

Keywords

Testosterone

Outcome Measures

Primary Outcomes (1)

• Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period

  84 days

Secondary Outcomes (3)

• Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)

  Baseline (Day -28 to Day 0) and End of Study (Day 57 to 84)

• Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84

  Day 0 and Day 84

• Change in Global Sexual Functioning From Day 0 to Day 84

  Day 0 and Day 84

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event

Drug: Placebo

Experimental 1

EXPERIMENTAL

Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn

Drug: Low dose TBS-2

Experimental 2

EXPERIMENTAL

Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn

Drug: Medium dose TBS-2

Experimental 3

EXPERIMENTAL

High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn

Drug: High dose TBS-2

Interventions

Placebo DRUG

placebo intranasal gel administered prn, 2-8 hours before a planned sexual event

Placebo

Low dose TBS-2 DRUG

Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

Experimental 1

Medium dose TBS-2 DRUG

Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

Experimental 2

High dose TBS-2 DRUG

High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

Experimental 3

Eligibility Criteria

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

You may qualify if:

• Subjects who meet the following criteria may be included in the study:
• At Visit 1:≤
• Be a generally healthy female aged 18 years and older, inclusive, who has no physical impediment to sexual function
• Have a diagnosis of acquired female orgasmic disorder defined as absence of orgasm during the past 6 months and according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria. Subtype should be generalized and not due to etiological factors that would be unlikely to be related to hormone function (eg, depression, relationship discord, alcoholism, surgery, injury). Hypoactive sexual desire disorder as a co-morbid disorder is allowed only if it began after the female orgasmic disorder diagnosis;
• Have a score of \>15 with a score of ≥2 for question #15 on the FSDS DAO at Screening Visit;
• Be a sexually active, hetero- or homosexual woman in a steady relationship for at least 6 months and agree to have at least 4 sexual events over 28-day period of time. The subject's partner should not have any untreated sexual dysfunctions;
• Be on a reliable birth control method (ie, stable systemic hormonal contraception for the whole duration of the study and 30 days after study completion \[for at least 3 months prior to study\], IUD, barrier method) or not engaging in heterosexual intercourse. Birth control method used by subject at screening is not to be changed during the course of the study;
• Have a normal ENT examination;
• Have a body mass index ≤35;
• Have a clinically acceptable pelvic examination and Pap smear as read by a licensed laboratory facility (no evidence of malignancy) within the 2 years prior to Randomization;
• Have a clinically acceptable mammogram;
• Be able to complete a web-based questionnaire within 24 hours of each sexual event;
• Be able to read English and provide written informed consent; and
• At Visit 2:
• Have at least 4 sexual events and an absence of orgasm during the 28 day Screening/Baseline Period as determined by MONASH WHP FSSQ.

You may not qualify if:

• Subjects who meet any of the following criteria will not be eligible to participate in the study:
• Have a known history of hypersensitivity to testosterone or any component of the study drug;
• Have a history of any clinically relevant psychiatric disorder that could impact sexual functioning, contribute to increased risk for patient safety, or significantly compromise participation in the study (eg, bipolar disorders, psychotic disorders, severe anxiety, eating disorders, borderline personality disorder, untreated Major Depressive Disorder);
• Have a score of ≥14 on the Beck Depression Inventory II at Screening Visit. Subjects with a score of ≥14 and ≤19 at Screening may be eligible to participate in the study if a specialist (psychologist or psychiatrist) concludes that the subject is not clinically depressed;
• Have other concurrent female sexual dysfunction disorders as defined by DSM-IV criteria, eg, Sexual Aversion Disorder, Substance-Induced sexual dysfunction, dyspareunia (not caused by inadequate foreplay stimulation or alleviated by lubricants), vaginismus, Gender Identity Disorder, paraphilia, or sexual dysfunction due to a general medical condition;
• Be experiencing relational discord;
• Have a history of dementia or other neurodegenerative diseases, organic brain disease, stroke, transient ischemic attacks, brain surgery, significant brain trauma, multiple sclerosis, spinal cord injury, peripheral neuropathy, and epilepsy (febrile seizures limited to childhood do not exclude patients);
• Be currently receiving treatment with selective norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) and/or medications that interfere with the metabolism of testosterone (eg, anastrozole, clomiphene, testolactone, ketoconazole, spironolactone, histamine 2 \[H2 receptor blockers, etc.\]);
• Have a history of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or be a regular drinker of more than 3 units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit);
• Have a history of cancer other than nonmelanotic skin cancer;
• Have a history of deep venous thrombosis or coagulation disorders;
• Have a significant medical condition (eg, hepatic, renal cardiovascular, endocrine including diabetes mellitus). Subjects with treated hypertension, treated hyperlipidemia, or treated thyroid disease will not be excluded provided they have been on stable therapy for at least 3 months;
• Had any major surgical procedure within the past 6 months including hysterectomy, hysterectomy with bilateral salpingo oophorectomy, or vaginal incontinence surgery
• Are receiving treatment with systemic glucocorticosteroids, sex steroid hormones such as androgens (eg, dehydroepiandrosterone \[DHEA\]) or gestagens (eg, anabolic steroids) and using any post menopausal hormone therapy;
• Have a history of severe or multiple drug allergies, severe adverse drug reaction or drug-related leucopenia;

Sponsors & Collaborators

• Acerus Pharmaceuticals Corporation: lead

Study Sites (53)

Radiant Research

Birmingham, Alabama, 35209, United States

Location

Medical Affiliated Research Center Inc.

Huntsville, Alabama, 35801, United States

Location

Radiant Research Inc.

Chandler, Arizona, 85224, United States

Location

Quality of Life Medical Research Center

Tucson, Arizona, 85712, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Downtown Women's Health Care

Denver, Colorado, 80218, United States

Location

Radiant Research Inc.

Denver, Colorado, 80239, United States

Location

Thameside OB/GYN Centre

Groton, Connecticut, 06340, United States

Location

Greater Hartford Women's Health Associates

Hartford, Connecticut, 06117, United States

Location

Tampa Bay Medical Research Inc.

Clearwater, Florida, 33761, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Clinical Physiology Associates

Fort Myers, Florida, 33916, United States

Location

University of Florida - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Compass Research East LLC

Oviedo, Florida, 32765, United States

Location

Center for Marital and Sexual Health of South Florida

West Palm Beach, Florida, 33401, United States

Location

Atlanta North Gynecology, PC

Roswell, Georgia, 30075, United States

Location

Women's Health Practice

Champaign, Illinois, 61820, United States

Location

Radiant Research Inc.

Chicago, Illinois, 60654, United States

Location

Radiant Reseach

Overland Park, Kansas, 66202, United States

Location

Maryland Center for Sexual Health

Lutherville, Maryland, 21093, United States

Location

QUEST Research Institute

Bingham Farms, Michigan, 48025, United States

Location

Radiant Research Inc.

Edina, Minnesota, 55435, United States

Location

Montana Health Research Institute

Billings, Montana, 59102, United States

Location

Womens Clinic of Lincoln P.C.

Lincoln, Nebraska, 68510, United States

Location

Columbia University School of Nursing

New York, New York, 10032, United States

Location

Wake Research Associates LLC

Raleigh, North Carolina, 27612, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58103, United States

Location

Radiant Research

Akron, Ohio, 44311, United States

Location

Center for Marital and Sexual Health Inc.

Beachwood, Ohio, 44122, United States

Location

Columbus Center for Women's Health Research

Columbus, Ohio, 43213, United States

Location

University Hospitals Case Medical Center

Mayfield Heights, Ohio, 44124, United States

Location

Cincinnati Urogynecology Associates (TRIHEALTH)

West Chester, Ohio, 45069, United States

Location

Clinical Research of Philadelphia LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Clinical Research Associates, Inc

Nashville, Tennessee, 37203, United States

Location

Radiant Research Inc.

Dallas, Texas, 75231, United States

Location

Texas Diabetes and Endocrinology

Round Rock, Texas, 78681, United States

Location

Radiant Research Inc.

San Antonio, Texas, 78229, United States

Location

San Antonio Psychiatric Research Center Dba Croft Group Research Center

San Antonio, Texas, 78229, United States

Location

University of Virginia Center for Psychiatric Clinical Research

Charlottesville, Virginia, 22903, United States

Location

Virginia Research Center

Midlothian, Virginia, 23114, United States

Location

Tidewater Physicians for Women

Norfolk, Virginia, 23502, United States

Location

Women's Clincial Research Center

Seattle, Washington, 98105, United States

Location

Monash University

Melbourne, 3004, Australia

Location

Keogh Institute for Medical Research

Nedlands, 6009, Australia

Location

The Robinson Institute University of Adelaide

North Adelaide, 5006, Australia

Location

Barbara Gross Research Unit

Randwick, 2031, Australia

Location

Alta Clinical Research Inc.

Edmonton, Alberta, T5A 4L8, Canada

Location

Gain Medical Centre

Coquitlam, British Columbia, V3K 3P4, Canada

Location

Discovery Clinical Services, Ltd

Victoria, British Columbia, V8T 5G4, Canada

Location

Victoria Clinical Research Inc

Victoria, British Columbia, V8V 3N7, Canada

Location

Manitoba Clinic

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Manna Research

Toronto, Ontario, M9W 4L6, Canada

Location

Results Point of Contact

• Title: Dr. Nathan Bryson, Chief Scientific Officer
• Organization: Acerus Pharmaceuticals Corporation

nbryson@aceruspharma.com

1-416-679-0776

Study Officials

• Natalia Tkachenko, MD

  Trimel Pharmaceuticals Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 30, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 13, 2018
• Results First Posted: August 13, 2018

Record last verified: 2018-08

Locations

CA (6); US (43); AU (4)