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Trial registered on ANZCTR


Registration number
ACTRN12610001079033
Ethics application status
Approved
Date submitted
7/12/2010
Date registered
8/12/2010
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Transdermal testosterone therapy: a potential treatment for selective serotonin reuptake inhibitor (SSRI)-associated sexual dysfunction in women.
Scientific title
Transdermal testosterone therapy: A potential treatment for selective serotonin reuptake inhibitor (SSRI) - associated sexual dysfunction in women being treated for depression
Secondary ID [1] 253250 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sexual dysfunction in women at midlife being treated for depression 258778 0
Condition category
Condition code
Reproductive Health and Childbirth 258921 258921 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of 300 micrograms/day transdermal testosterone via skin patch applied by the patient twice weekly. Patients will be required to wear the patch for 84 hours each time before removal. Patients will undergo the intervention treatment for 3 months.
Intervention code [1] 257715 0
Treatment: Drugs
Comparator / control treatment
Adminstration of identical placebo patch twice weekly. The placebo patch is a transparent polyester/ethylene vinyl acetate bi-layer film laminate backing, an adhesive formulation containing acrylic adhesive, silicone adhesive, oleyl alcohol, and povidone. The duration of the control treatment is 3 months.
Control group
Placebo

Outcomes
Primary outcome [1] 259788 0
to assess the efficacy of transdermal testosterone therapy on sexual function over 3 months in a randomised placebo controlled trial in women at midlife being treated for depression with a selective serotonin re-uptake inhibitor (SSRI) who are experiencing at least one of: loss of sexual desire, sexual arousal disorder or delayed orgasm/anorgasmia for which they desire treatment. . The primary endpoint will be change from baseline in the total score of the Sabbatsberg Sexual Self-rating Scale (SSS).
Timepoint [1] 259788 0
At baseline and at 3 months
Secondary outcome [1] 268570 0
to assess the effects of testosterone therapy in these women on the individual domains of sexual function included in the Sabbatsberg Sexual Self-rating Scale (SSS) (sexual desire, arousal, fantasy, orgasm, satisfaction, pleasure and relevance).
Timepoint [1] 268570 0
3 months
Secondary outcome [2] 268589 0
to assess the effects of testosterone therapy in these women on the total score for the Female Sexual Distress Scale-Revised (FSDS-R).
Timepoint [2] 268589 0
3 months
Secondary outcome [3] 268590 0
to assess the effects of testosterone therapy in these women on wellbeing using the Psychological General Well-Being Index and its domains
Timepoint [3] 268590 0
3 months
Secondary outcome [4] 268591 0
to assess the effects of testosterone therapy in these women on depression using the Beck Depression Inventory-II (BDI)
Timepoint [4] 268591 0
3 months
Secondary outcome [5] 268592 0
to assess the effects of testosterone therapy in these women on mood using the Profile of Mood States (POMS)
Timepoint [5] 268592 0
3 months
Secondary outcome [6] 268593 0
to assess the effects of testosterone therapy in these women on recording of the frequency of satisfactory sexual events over 28 days by diary
Timepoint [6] 268593 0
3 months

Eligibility
Key inclusion criteria
Women:
1. who are aged 35 to 55 years on a stable dose of a Selective Serotonin Reuptake Inhibitor (sertraline, citalopram, paroxetine, fluoxetine or fluvoxamine) or a Selective Noradrenaline Reuptake Inhibitor (venlafaxine) for at least 3 months
2. are using a medically acceptable form of contraception: oral contraceptives (except those with antiandrogen component), injectable or implantable methods, intrauterine devices, properly used barrier contraception, bilateral tubal ligation or involvement in a monogamous relationship with a partner who has had a vasectomy (not required for hysterectomised / oophorectomised women or women with evidence of being >2 years postmenopausal),
3. have a negative pregnancy test at screening (not required for hysterectomised / oophorectomised women or women with evidence of being >2 years postmenopausal),
4. if using hormone replacement therapy have been on a stable dose for >3 months, excluding conjugated oestrogen (Premarin) or drospirenone.
5. have a clinically acceptable screening mammogram or documented results of a previous mammogram within 2 years of screening for women over 50 years;
6. have a clinically acceptable Pap smear within the past 2 years(no evidence of malignancy or squamous intraepithelial lesions) if the cervix is present;
7. who have provided informed consent by signing the approved consent agreement
Minimum age
35 Years
Maximum age
55 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women with any of the following: (a) Have not had sexual function they consider satisfactory, prior to this episode of treatment for depression (b) Have a Body Mass Index<18 or > 40kg/m2 (c) Not sexually active (at least one sexual event per 28 days alone or with a partner) (d) Are found on the screening questionnaire to be experiencing any of the following: planning a pregnancy, breast feeding, significant dyspareunia; partnership problems / poor feeling for partner. (e) Have a Beck Depression Inventory-11 (BDI-II) score on screening > 28 ie severe depression (f) Have a sexual pain disorder (g) Have used recent androgen therapy (testosterone implant < 16 weeks ago, transdermal testosterone cream < 8 weeks ago, tibolone < 12 weeks ago, oral testosterone <4 weeks ago, injected testosterone<6 weeks ago) (h) Have sexual dysfunction caused by another medical condition (i) Current use of hormone replacement therapy containing conjugated oestrogen (Premarin) (j) Screening Sex Hormone Binding Globulin (SHBG)>160nmol/L (k) Have renal disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina at any time before study entry or thrombo-phlebitis within the last 5 years, or any other major illness that has occurred within the last 6 months. (l) Have undiagnosed genital bleeding (m) Have moderate to severe acne or hirsutism, have used antiandrogen therapy for acne or hirsutism in the preceding 5 years, have androgenic alopecia ( will exclude women with clinically meaningful androgen excess) (n) Active malignancy, or treatment for malignancy in the preceding 6 months (excluding non-melanotic skin cancer) (o) Report alcohol consumption > 3 standard drinks per day. (p) Have an abnormal thyroid stimulating hormone (TSH) value at screening confirmed by a Free T4 outside the normal laboratory range (patients with an abnormal TSH, normal Free T4 and no clinical signs or symptoms of thyroid disease, with or without replacement treatment, may be admitted to the study). (q) Have a history of Bipolar Disorder or Schizophrenia (r) Have a history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation (s) Any clinically significant skin abnormalities in the area of study drug application (Skin Irritation Scale must < 1 at Visit 2). 2. Women who, in the opinion of the investigator, are a poor medical or psychiatric risk for treatment in a research protocol. 3. Women who have participated in a medical or surgical research protocol in the preceding 28 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from advertisements in the media and from flyers within medical clinics seeing patients suffering from depression. All participants will have voluntarily provided their telephone details before being contacted by the Research Unit. Participants will initially be contacted by telephone by researchers working on the study. They will be assessed with regards to their suitability to be involved in the study. Those who are deemed suitable will be mailed the participant information sheet to read at their leisure. Those patients who wish to participate will be instructed to contact the Trial Co-ordinator to arrange a visit to the Women's Health Research Program, Monash University , The Alfred Centre, for a screening visit.

Allocation concealment will be done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization schedule will be computer generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258180 0
University
Name [1] 258180 0
Monash University
Address [1] 258180 0
Monash University, Wellington Road Clayton VIC 3800
Country [1] 258180 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University,Clayton Campus, Wellington Road, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 257356 0
None
Name [1] 257356 0
Address [1] 257356 0
Country [1] 257356 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260170 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 260170 0
Human Ethics Office First Floor,
Building 3E, Room 111
Monash University Clayton Campus,
Wellington Rd, Clayton,
VIC 3800
Ethics committee country [1] 260170 0
Australia
Date submitted for ethics approval [1] 260170 0
Approval date [1] 260170 0
29/11/2010
Ethics approval number [1] 260170 0
CF10/2629-2010001469

Summary
Brief summary
The Primary Aim of this study is to assess the efficacy of transdermal testosterone therapy on sexual function over 3 months in women at midlife being treated for depression with a selective serotonin re-uptake inhibitor (SSRI) who are experiencing at least one of: loss of sexual desire, sexual arousal disorder or delayed orgasm/anorgasmia for which they desire treatment Study hypothesis Transdermal testosterone, compared with placebo, will result in a clinically meaningful improvement in the total score of the Sabbatsberg Sexual Self Rating Scale indicating improvement in sexual dysfunction secondary to the use of SSRI/SNRI medication .
Trial website
Trial related presentations / publications
J Sex Med. 2014 Mar;11(3):831-9. doi: 10.1111/jsm.12426. Epub 2014 Jan 16.
Testosterone improves antidepressant-emergent loss of libido in women: findings from a randomized, double-blind, placebo-controlled trial.
Fooladi E1, Bell RJ, Jane F, Robinson PJ, Kulkarni J, Davis SR.
Public notes

Contacts
Principal investigator
Name 31996 0
Prof Susan Davis
Address 31996 0
Women's Health Research Program Monash University Level 6,The Alfred Centre 99 Commercial Road Melbourne VIC 3004
Country 31996 0
Australia
Phone 31996 0
+61 3 9903 0827
Fax 31996 0
+61 3 9903 0828
Email 31996 0
susan.davis@monash.edu
Contact person for public queries
Name 15243 0
Prof Susan Davis
Address 15243 0
Women's Health Research Program
Monash University
Level 6,The Alfred Centre
99 Commercial Road
Melbourne
VIC 3004
Country 15243 0
Australia
Phone 15243 0
+61 3 9903 0827
Fax 15243 0
+61 3 9903 0828
Email 15243 0
susan.davis@monash.edu
Contact person for scientific queries
Name 6171 0
Prof Susan Davis
Address 6171 0
Women's Health Research Program
Monash University
Level 6,The Alfred Centre
99 Commercial Road
Melbourne
VIC 3004
Country 6171 0
Australia
Phone 6171 0
+61 3 9903 0827
Fax 6171 0
+61 3 9903 0828
Email 6171 0
susan.davis@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary