Hypoactive sexual desire disorder MedDRA version: 7.0 Level: PT Classification code 10020933
Conditions
Interventions
Product Name: Testosterone
Product Code: N/A
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Testosterone
CAS Number: 58-22-0
Concentration unit: µg microgram(s)
Concentration type: equal
Sponsors
Procter and Gamble Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) For surgically menopausal women, be 20-70 years of age, nad at least 12 month post menopause 2) For naturally menopausal women, be 40-70 years of age, and at least 2 years post menopause 3) For women>_ 40 years of age, have a clinically acceptable screening bilateral mammogram 4) Have a clinically acceptable Pap smear if the cervix is present 5) For naturally women with uterus, have an adequate endometrial status, as assessed by a transvaginal ultrasound, with 12nmol/L 8) Be able and willing to participate in the study, providing written informed consent 9) Required questions has to be affirmatively answered by subject For more information, please refer to the protocol section 3.2.1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Have dyspareunia, physical limitations, experienced sexual trauma 2) Have used estrogen or estrogen progestin therapy in the last 12 weeks or are in need of hormonal therapy 3) Have naturally menopausal women, hysterectomized or previously on hormonal therapy within the last 2 years 4) Have used any androgen therapy at any time during the last 3 months 5) Have received any antiandrogen therapy within the last 5 years 6) Have used within the last 12 weeks any of the following medications: systemic cortisteroids, SSRI's, tricyclic anti-depressant, anti-androgens, betablockers, anti-andrenergics, spironolactone, apomorphine, PDE5 inhibitors, tribolone, or SERMs, including tamoxifen 7)Have used: DHEA or other drugs or supplements that may affect your sexual function, in the past 30 days 8) Have used phyto-estrogens for less than 12 weeks prior to visit 1 (week-4) 9) Be experiencing any chronic or acute life stress, that interfere with sexual function 10) Have psychiatric disorder, alcohol or drug dependence 11) Have severe dermatological problems 12)Have hypersensitivity or allergy to any of the constituents of the patch 13) Have participated in a irritation test within 12 weeks 14) Have evidence of clinically significant organic disease on the history and/or physical exam that would, in the opinion of the Investigator, put the patient at risk, prevent the patient from completing the study, or otherwise affect the outcome of the study 15) If an endometrial biopsy is performed, have evidence of malignancy or pre-malignancy/hyperplasia, as scored by the central pathology facility 16) Have a history of breast cancer or estrogen-dependent neoplasia (e.g. endometrial cancer) or any gynecological cancer at any time before study entry or other cancer (except basal or squamous cell carcinoma) within the last 5 years 17) Have had gynecological or breast surgery within the last 6 months; 18) Have acute liver or renal disease, or any other major illness which has occurred within the last 6 months 19) Have diabetes mellitus 20) Have had active gallbladder disease during the 6 months prior to the study 21) Have a history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina at anytime before study entry or thrombo-phlebitis within the last 5 years 22) Have an abnormal 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) 23) Have, in the opinion of the Investigator, clinically significant abnormal pretreatment laboratory parameters (a single, repeat assay will be allowed if an assay result is questionable) 24) Have the following abnormal pretreatment laboratory parameters (a single repeat will be allowed if an assay result is questionable): - Serum creatinine >2.5 mg/dL - Serum total bilirubin >2 times the upper limit of normal - ALT or AST >3 times the upper limit of normal For more information, please refer to the protocol section 3.2.2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of trandermal testosterone patch therapy in naturally or surgically menopausal women who are not receiving systemic estrogen or estrogen progestin therapy. Efficacy will be measured by the change from week 0 (Baseline) to week 24 in a 4-week frequency of total satisfying episodes (intercourse and non-intercourse), as reported on the Sexual Activity Log (SAL). Safety of the transdermal testosterone patch therapy in these women will be assessed by the collecting adverse events (AEs), androgenic assessments, lipid/lipoprotein and carbohydrate profiles, and other safety parameters. Serum concentrations of free, total, and bioavailable testosterone, total DHT, free and total estradiol, estrone and SHBG will be determined.;Secondary Objective: To assess the efficacy of transdermal testosterone patch therapy in naturally or surgically menopausal women, as measured by the change from baseline to week 24, in the following parameters (listed in order to importance): 1) The sexual Desire domain of the profile of Female Sexual Function (PFSF) 2) The personal Distress Scale (PDS) 3) Other domains of the PFSF and other SAL endpoints 4) Mood, energy and well-being using the Phychological General Well-Being (PGWB) and the Profile of Mood States (POMS) 5) Menophausal symptoms as assessed by the Greene Climacteric Scale 6) All of the above will also be assessed at 12 weeks ;Primary end point(s): The primary efficacy endpoint will be the change from baseline in the 4-week frequency of total satisfying episodes (from intercourse and non-intercourse-related activity) at 24 weeks (sum of the weekly frequencies of total satisfying episodes from the SAL at weeks 21-24). | — |
Countries
Sweden
Outcome results
None listed