E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multi-center, double-blind, placebo-controlled study to investigate the efficacy and safety of daily oral 100 mg dehydroepiandrosterone (DHEA) over 6 treatment cycles as a concomitant therapy to oral contraceptives (OC) to alleviate complaints of reduced libido in women with acquired female sexual disorder (FSD) associated with OC-use |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040477 |
E.1.2 | Term | Sexual dysfunction |
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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 investigate the effects of 100 mg DHEA per day in women on continuous treatment with a monophasic combined oral contraceptive (COC) who suffer from an acquired OC-associated HSDD as a perceived adverse drug reaction to their OC use. The primary objective will consist of the combined sexual arousal and desire domains of the Female Sexual Function Index (FSFI) self-report questionnaire |
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E.2.2 | Secondary objectives of the trial |
• to better define the study population, the endpoints and the sample size for future Phase 2 and 3 clinical trials • to better understand hormonal levels in women with sexual dysfunction and their changes under treatment with DHEA • to investigate the tolerability of DHEA and to further evaluate its adverse drug reaction profile • to determine the exposure of DHEA and some important metabolites like DHEA-S, testosterone (T) and estradiol (E2) and to investigate their potential impact on the SHBG
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed and dated informed consent 2. Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive) at visit 1 3. Women on treatment with a monophasic combined oral contraceptive (COC) and suffering from reduced libido as a perceived side effect of the OC use (i.e.acquired OC-associated HSDD) for at least 3 months and willing to continue the particular OC that they have been using. 4. Value of 18 or below in the not weighted sum score of the sexual desire and arousal domain of the FSFI questionnaire at screening and baseline. 5. Sexual relationship with a sexually competent partner 6. Non-suspicious cervical smear taken at visit 1 or within the last 3 months before visit 1
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E.4 | Principal exclusion criteria |
1) Female sexual dysfunction other than HSDD, such as sexual aversion/phobic disorder, sexual pain disorder/dyspareunia 2) Hyperandrogenemic conditions, such as congenital adrenal hyperplasia (CAH), polycystic ovary syndrome (PCOS), Cushing’s syndrome or signs of hyperandrogenism like severe hirsutism or severe acne 3) Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident. 4) Presence or history of prodromi of a thrombosis (e.g., transient ischaemic attack, angina pectoris). 5) History of migraine with focal neurological symptoms. 6) Diabetes mellitus with vascular involvement. 7) Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis 8) Pancreatitis or a history thereof if associated with severe hypertriglyceridemia 9) Presence or history of severe hepatic disease as long as liver function values have not returned to normal. 10) Presence or history of liver tumors (benign or malignant). 11) Known or suspected sex-steroid influenced malignancies (e.g., of the genital organs or the breasts) 12) Undiagnosed vaginal bleeding. 13) Known or suspected pregnancy. 14) Hypersensitivity to the active substances or to any of the excipients.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy variable will be the change from baseline (visit 2) to cycle 6 (visit 5) in the not weighted sum of FSFI sexual desire and the sexual arousal component scores, defined as the total of questions 1 to 6 of the FSFI |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 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 | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |