| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Hypoactive sexual desire disorder |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 7.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10020933 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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. |
|
| E.2.2 | Secondary objectives of the trial |
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 |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal 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<_ 4 mm endometrial double thickness and no other abnormal findings
6) Be, in their own judgement, in a stable monogamus sexual relationship for at least one year, who is sexually functional and present at least 50% of each monthduring the 4-week pretreatmentand the 24-week efficacy period
7) Have an SHBG value > 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 |
|
| E.4 | Principal 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
|
|
| E.5 End points |
| E.5.1 | 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). |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The end of the study is when the last patient has completed the last visit. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 7 |
| E.8.9.1 | In the Member State concerned days | |
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