E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
sexual/ erectile function in women and men after treatment for rectal cancer |
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E.1.1.1 | Medical condition in easily understood language |
sexual/ erectile function in women and men after treatment for rectal cancer |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10013356 |
E.1.2 | Term | Sexual function and fertility disorders |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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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 evaluate the effect of prophylactic intake of 5 mg tadalafil on sexual/ erectile function in women and men within a standardized rehabilitation program after treatment for rectal cancer. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of: 1. prophylaxis of 5 mg tadalafil on severe sexual dysfunction (women) and on severe erectile dysfuntion (men) after treatment of rectal cancer. 2. prophylaxis of 5 mg tadalafil on sexual activity in women after treatment of rectal cancer. 3. prophylaxis of 5 mg tadalafil on attempt to intercourse in women after treatment of rectal cancer 4. prophylaxis of 5 mg tadalafil on sexual activity in men after treatment of rectal cancer. 5. number of patients with use of PDE5-inhibitors at own cost between 6 and 24 months after surgery. 6. prophylaxis of 5 mg tadalafil on genital fibrosis after treatment of rectal cancer. 7. prophylaxis of 5 mg tadalafil on androgen levels after treatment of rectal cancer. 8. prophylaxis of 5 mg tadalafil on bowel function after treatment of rectal cancer. 9. prophylaxis of 5 mg tadalafil on urinary function after treatment of rectal cancer. 10. the safety and tolerability of 5 mg tadalafil during treatment of rectal cancer. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men and women with rectal cancer stage I-III after clinical and radiologic staging, intention to transabdominal resection of rectal cancer. 2. Patient reported sexual activity before diagnosis or symptoms of rectal cancer according to FSFI-6 and IIEF-5. 3. Age over 18 years 4. Fluent in oral and written Swedish language 5. Females must not be lactating or pregnant at baseline documented by pregnancy test. 6. Given written informed consent |
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E.4 | Principal exclusion criteria |
1. Evidence of systemic disease (metastases) 2. History or evidence of urogenital malignancy 3. History of pelvic radiation 4. Concomitant use of anti-androgens or androgens 5. Contraindications to the use of tadalafil (PDE5-inhibitor) 6. Impaired performance status (Eastern Cooperative Oncology Group (ECOG) performance score above 1. 7. Serious co-existing mental disorder or medical condition e.g. anaemia, liver or renal failure, cardiovascular disease or diabetes. 8. Ongoing drug or alcohol abuse dependence. 9. Has a condition or has received medical treatment that, in the judgement of the investigator, precluded successful participation in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Women: Change between baseline and 24 months in sexual function assessed with the total score of the Female Sexual Function Index (FSFI-6). Men: Change between baseline and 24 months in erectile function assessed with the total score of the short version of the International Index of Erectile Function (IIEF-5). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Change from baseline to 24 months on the proportion of women with severe sexual dysfunction defined as a FSFI-6 score below 20 at baseline and the proportion of men with severe erectile dysfunction defined as IIEF-5 score of 5-7 at baseline. 2. Change from baseline to 24 months on the proportion of sexually active women defined as score 0 on question 2, 3 or 4 in the FSFI-6 questionnaire at baseline. 3. Change from baseline to 24 months on the proportion of women who attempt intercourse defined as score 0 on question 6 in the FSFI-6 questionnaire at baseline. 4. Change from baseline to 24 months on the proportion of sexually active men defined as score “X” (no sexual activity) on question 2, 3, 4 or 5 in the IIEF-5 questionnaire at baseline. 5. Proportion of patients with use of PDE5-inhibitors at least once per month between 6-24 months after surgery for rectal cancer (PDE5-inhibitors users). 6. Fibrosis: 6.1. Women: Change from baseline to 24 months in size of pain-free introducible vaginal dilator (4 categories). 6.2. Men: Change from baseline to 24 months in penile length in flaccid state 7. Change from baseline to 24 months in total and free testosterone, LH, albumin and sex hormone binding globuline (SHBG). 8. Change from baseline to 24 months in Low Anterior Resection Syndrome Score (LARS) or the Colostomy Impact Score (CI) respectively. 9. Change from baseline to 24 months in urinary function (questionnaire) – descriptive statistics. 10. Adverse events from baseline to 6 months after surgery for rectal cancer. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | No |
E.6.10 | Pharmacogenetic | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard care, rehabilitation program |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |