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

NCT ID: NCT01607658

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Experimental 1

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

Group Type: EXPERIMENTAL

Low dose TBS-2

Intervention Type: DRUG

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

Experimental 2

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

Group Type: EXPERIMENTAL

Medium dose TBS-2

Intervention Type: DRUG

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

Experimental 3

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

Group Type: EXPERIMENTAL

High dose TBS-2

Intervention Type: DRUG

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

Interventions

Placebo

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

Intervention Type: DRUG

Low dose TBS-2

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

Intervention Type: DRUG

Medium dose TBS-2

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

Intervention Type: DRUG

High dose TBS-2

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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;
• Have a history of nasal disorders (eg, atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal septum deviation, recurrent epistaxis), sinus disease or nasal surgery and/or seasonal or perennial allergic rhinitis in the active phase;
• Be using any form of chronic intranasal medication delivery, specifically nasal corticosteroids or decongestants;
• Have a diagnosis of sleep apnea and be using a continuous positive airway pressure/automatic positive airway device;
• Have a history of diagnosed hirsutism, alopecia or clinically significant acne;
• Have a history of diagnosed polycystic ovarian syndrome;
• Have pelvic inflammatory disease, chronic urinary tract, vaginal, or cervical infections, interstitial cystitis, vulvodynia, or significant symptomatic vaginal atrophy;
• Are currently pregnant, by history or positive serum pregnancy test at Screening Visit or have been pregnant within the 12 months prior to Screening Visit;
• Is breast feeding or have breast fed within the 6 months prior to Screening Visit;
• Are positive for hepatitis B-surface antigen, hepatitis C, or Human Immunodeficiency Virus (HIV);
• Have abnormal thyroid stimulating hormone level;
• For pre-menopausal women, have SHBG value <18 86 nmol/L; For post-menopausal women, have SHBG value >160 nmol/L
• Have any medical or psychiatric condition, physical examination finding, or laboratory result which, in the opinion of the principal investigator, would put the subject at additional medical risk or make her unlikely to be able to comply with study requirements; or
• Have received any drug as part of a research study within 30 days prior to the Screening Visit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Acerus Pharmaceuticals Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalia Tkachenko, MD

Role: STUDY_DIRECTOR

Trimel Pharmaceuticals Corporation

Locations

Radiant Research

Birmingham, Alabama, United States

Medical Affiliated Research Center Inc.

Huntsville, Alabama, United States

Radiant Research Inc.

Chandler, Arizona, United States

Quality of Life Medical Research Center

Tucson, Arizona, United States

Medical Center for Clinical Research

San Diego, California, United States

San Diego Sexual Medicine

San Diego, California, United States

Downtown Women's Health Care

Denver, Colorado, United States

Radiant Research Inc.

Denver, Colorado, United States

Thameside OB/GYN Centre

Groton, Connecticut, United States

Greater Hartford Women's Health Associates

Hartford, Connecticut, United States

Tampa Bay Medical Research Inc.

Clearwater, Florida, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

Clinical Physiology Associates

Fort Myers, Florida, United States

University of Florida - Jacksonville

Jacksonville, Florida, United States

Compass Research East LLC

Oviedo, Florida, United States

Center for Marital and Sexual Health of South Florida

West Palm Beach, Florida, United States

Atlanta North Gynecology, PC

Roswell, Georgia, United States

Women's Health Practice

Champaign, Illinois, United States

Radiant Research Inc.

Chicago, Illinois, United States

Radiant Reseach

Overland Park, Kansas, United States

Maryland Center for Sexual Health

Lutherville, Maryland, United States

QUEST Research Institute

Bingham Farms, Michigan, United States

Radiant Research Inc.

Edina, Minnesota, United States

Montana Health Research Institute

Billings, Montana, United States

Womens Clinic of Lincoln P.C.

Lincoln, Nebraska, United States

Columbia University School of Nursing

New York, New York, United States

Wake Research Associates LLC

Raleigh, North Carolina, United States

Lillestol Research LLC

Fargo, North Dakota, United States

Radiant Research

Akron, Ohio, United States

Center for Marital and Sexual Health Inc.

Beachwood, Ohio, United States

Columbus Center for Women's Health Research

Columbus, Ohio, United States

University Hospitals Case Medical Center

Mayfield Heights, Ohio, United States

Cincinnati Urogynecology Associates (TRIHEALTH)

West Chester, Ohio, United States

Clinical Research of Philadelphia LLC

Philadelphia, Pennsylvania, United States

Clinical Research Associates, Inc

Nashville, Tennessee, United States

Radiant Research Inc.

Dallas, Texas, United States

Texas Diabetes and Endocrinology

Round Rock, Texas, United States

Radiant Research Inc.

San Antonio, Texas, United States

San Antonio Psychiatric Research Center Dba Croft Group Research Center

San Antonio, Texas, United States

University of Virginia Center for Psychiatric Clinical Research

Charlottesville, Virginia, United States

Virginia Research Center

Midlothian, Virginia, United States

Tidewater Physicians for Women

Norfolk, Virginia, United States

Women's Clincial Research Center

Seattle, Washington, United States

Monash University

Melbourne, , Australia

Keogh Institute for Medical Research

Nedlands, , Australia

The Robinson Institute University of Adelaide

North Adelaide, , Australia

Barbara Gross Research Unit

Randwick, , Australia

Alta Clinical Research Inc.

Edmonton, Alberta, Canada

Gain Medical Centre

Coquitlam, British Columbia, Canada

Discovery Clinical Services, Ltd

Victoria, British Columbia, Canada

Victoria Clinical Research Inc

Victoria, British Columbia, Canada

Manitoba Clinic

Winnipeg, Manitoba, Canada

Manna Research

Toronto, Ontario, Canada

Countries

United States; Australia; Canada

Other Identifiers

TBS-2-AMB-2012-01

Identifier Type: -

Identifier Source: org_study_id