Female Orgasmic DisorderPhase 2NCT01607658
Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder
A Phase 2 study testing Low dose TBS-2, Medium dose TBS-2 and High dose TBS-2 in people with Female Orgasmic Disorder, run by Acerus Pharmaceuticals Corporation at 53 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Orgasmic Disorder
- What is being tested?
- Low dose TBS-2, Medium dose TBS-2 and High dose TBS-2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 53 sitesin 3 countries
- Study dates
- May 2012to May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
53 sites in 3 countries.
53 sites in 3 countries
United States43 sites
Radiant Research
Akron, Ohio, 44311
Center for Marital and Sexual Health Inc.
Beachwood, Ohio, 44122
Montana Health Research Institute
Billings, Montana, 59102
QUEST Research Institute
Bingham Farms, Michigan, 48025
Radiant Research
Birmingham, Alabama, 35209
Women's Health Practice
Champaign, Illinois, 61820
Radiant Research Inc.
Chandler, Arizona, 85224
University of Virginia Center for Psychiatric Clinical Research
Charlottesville, Virginia, 22903
Radiant Research Inc.
Chicago, Illinois, 60654
Tampa Bay Medical Research Inc.
Clearwater, Florida, 33761
Columbus Center for Women's Health Research
Columbus, Ohio, 43213
Clinical Research of South Florida
Coral Gables, Florida, 33134
Radiant Research Inc.
Dallas, Texas, 75231
Downtown Women's Health Care
Denver, Colorado, 80218
Radiant Research Inc.
Denver, Colorado, 80239
Radiant Research Inc.
Edina, Minnesota, 55435
Lillestol Research LLC
Fargo, North Dakota, 58103
Clinical Physiology Associates
Fort Myers, Florida, 33916
Thameside OB/GYN Centre
Groton, Connecticut, 06340
Greater Hartford Women's Health Associates
Hartford, Connecticut, 06117
Medical Affiliated Research Center Inc.
Huntsville, Alabama, 35801
University of Florida - Jacksonville
Jacksonville, Florida, 32207
Womens Clinic of Lincoln P.C.
Lincoln, Nebraska, 68510
Maryland Center for Sexual Health
Lutherville, Maryland, 21093
University Hospitals Case Medical Center
Mayfield Heights, Ohio, 44124
Virginia Research Center
Midlothian, Virginia, 23114
Clinical Research Associates, Inc
Nashville, Tennessee, 37203
Columbia University School of Nursing
New York, New York, 10032
Tidewater Physicians for Women
Norfolk, Virginia, 23502
Radiant Reseach
Overland Park, Kansas, 66202
Compass Research East LLC
Oviedo, Florida, 32765
Clinical Research of Philadelphia LLC
Philadelphia, Pennsylvania, 19114
Wake Research Associates LLC
Raleigh, North Carolina, 27612
Atlanta North Gynecology, PC
Roswell, Georgia, 30075
Texas Diabetes and Endocrinology
Round Rock, Texas, 78681
Radiant Research Inc.
San Antonio, Texas, 78229
San Antonio Psychiatric Research Center Dba Croft Group Research Center
San Antonio, Texas, 78229
Medical Center for Clinical Research
San Diego, California, 92108
San Diego Sexual Medicine
San Diego, California, 92120
Women's Clincial Research Center
Seattle, Washington, 98105
Quality of Life Medical Research Center
Tucson, Arizona, 85712
Cincinnati Urogynecology Associates (TRIHEALTH)
West Chester, Ohio, 45069
Center for Marital and Sexual Health of South Florida
West Palm Beach, Florida, 33401
Canada6 sites
Gain Medical Centre
Coquitlam, British Columbia, V3K 3P4
Alta Clinical Research Inc.
Edmonton, Alberta, T5A 4L8
Manna Research
Toronto, Ontario, M9W 4L6
Discovery Clinical Services, Ltd
Victoria, British Columbia, V8T 5G4
Victoria Clinical Research Inc
Victoria, British Columbia, V8V 3N7
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M3
Australia4 sites
Monash University
Melbourne, 3004
Keogh Institute for Medical Research
Nedlands, 6009
The Robinson Institute University of Adelaide
North Adelaide, 5006
Barbara Gross Research Unit
Randwick, 2031
About this study
Official title: A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Efficacy and Safety of TBS-2 Intranasal Testosterone Gel in Women With Acquired Female Orgasmic Disorder
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
- Being tested
- Placebo, Low dose TBS-2, Medium dose TBS-2, High dose TBS-2
- Keywords
- Testosterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo intranasal gel administered prn, 2-8 hours before a planned sexual event
Low dose TBS-2Drug
Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
Medium dose TBS-2Drug
Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
High dose TBS-2Drug
High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event Receives: Drug: Placebo |
| Experimental 1 | Experimental | Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn Receives: Drug: Low dose TBS-2 |
| Experimental 2 | Experimental | Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn Receives: Drug: Medium dose TBS-2 |
| Experimental 3 | Experimental | High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn Receives: Drug: High dose TBS-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period
Measured: 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)
as measured by Monash Women's Health Program Female Sexual Satisfaction Questionnaire (MONASH WHP FSSQ) question 11.
MONASH WHP FSSQ question 11 asks participants to comment on how satisfying they found the sex to be from "Not at all" to "Very much so". The lowest score is 1 and the highest is 9. All scores for each 28-day period were averaged. Change from baseline was obtained by subtracting baseline 28-day average from the 28-day period at the end of the study (Day 57 to 84).
Measured: 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
as measured by Female Sexual Distress Scale (FSDS-DAO) Question #15 on Day 0 and 84, respectively. Question #15 evaluates the level of distress related to problems with orgasm. It is rated on a 5-point Likert scale (from 0 to 4, i.e. never [0], rarely [1], occasionally [2], frequently [3], or always [4]). Higher scores indicate more distress.
Measured: Day 0 and Day 84
Change in Global Sexual Functioning From Day 0 to Day 84
as measured by Female Sexual Function Index (FSFI) on Day 0 and 84, respectively. The FSFI, a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual frustration in women. The questionnaire provides scores on 6 domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) as well as a total score. Fifteen items are rated on a 6-point Likert scale (from 0 to 5) and 4 items on a 5-point Likert scale (from 1 to 5). The scores are added and converted using a conversion factor so that the maximum score for each domain is 6. The overall FSFI score can range from 2 to 36. Higher scores indicate better or higher sexual function.
Measured: Day 0 and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Female Orgasmic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerus Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalia Tkachenko, MD, Study director, Trimel Pharmaceuticals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607658
- Sponsor's protocol ID
- TBS-2-AMB-2012-01
- Status last verified
- Aug 2018
- First submitted
- 18 May 2012
- Last updated
- 13 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Efficacy and Safety of TBS-2 Intranasal Testosterone Gel in Women With Acquired Female Orgasmic Disorder
- ClinicalTrials.gov ID
- NCT01607658
- Acronym / sponsor ID
- TBS-2-AMB-2012-01
- Conditions
- Female Orgasmic Disorder
- Keywords
- Testosterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Acerus Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Posted 13 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo intranasal gel administered prn, 2-8 hours before a planned sexual event |
| Experimental 1 | Experimental | Drug: Low dose TBS-2Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn |
| Experimental 2 | Experimental | Drug: Medium dose TBS-2Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn |
| Experimental 3 | Experimental | Drug: High dose TBS-2High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (28 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboplacebo intranasal gel administered prn, 2-8 hours before a planned sexual event | Drug | Placebo |
| Low dose TBS-2Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event | Drug | Experimental 1 |
| Medium dose TBS-2Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event | Drug | Experimental 2 |
| High dose TBS-2High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event | Drug | Experimental 3 |
Primary outcome
Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period
Time frame: 84 days
3 secondary outcomes
Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)
Time frame: 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
Time frame: Day 0 and Day 84
Change in Global Sexual Functioning From Day 0 to Day 84
Time frame: Day 0 and Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Orgasmic Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Tkachenko, MD study director
Trimel Pharmaceuticals Corporation
53 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose TBS-2, Medium dose TBS-2 and High dose TBS-2 in people with Female Orgasmic Disorder, run by Acerus Pharmaceuticals Corporation at 53 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.