E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sexual dysfunction caused by the use of oral contraceptives |
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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 | 10057671 |
E.1.2 | Term | Female 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 determine the effect of concomitant DHEA compared to placebo in OC users on:
• the degree of sexual desire as measured by a single item: ‘To what extent did you feel like having sex in the past 24 hours?’ |
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E.2.2 | Secondary objectives of the trial |
• To determine the frequency of sexual desire over past 3 weeks of OC intake measured with item 4 from the Sexual Interest and Desire Inventory-Female (SIDI-F) • To determine the ease of sexual arousal (responsivity) over past 3 weeks of OC intake measured with item 11 from the Sexual Interest and Desire Inventory-Female (SIDI-F) • To determine the frequency of satisfying sexual events measured by the Sexual Event Log (SEL) • Satisfaction and health related quality of life measured by the short form of the Quality of Life Enjoyment and Satisfaction Questionnaire
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Women using OC for at least 3 months prior to screening and aged 20-35 years (inclusive) 2. Stable, heterosexual relationship for at least 3 months prior to screening (MMQ General Marital Satisfaction scale score ≤ 10). Partner is expected to be physically present at least 50% of each month for the duration of the study 3. Good physical and mental health as judged by the Investigator determined by medical and gynaecological history, physical examination, clinical laboratory and vital signs 4. Report of decline in sexual desire and or responsivity, and attributing this to OC use as evidenced by an FSFI Sexual desire scale score > 2.6 and an in depth interview 5. Regular menstrual cycles (24-35 days) prior to last start of OC use 6. Body mass index between (≥) 18 and (≤) 35 kg/m2 7. Non-depressed women, BDI-II Beck’s Depression Inventory score (<) 14. 8. Willing to give informed consent in writing
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E.4 | Principal exclusion criteria |
1. Androgen therapy during the 6 months prior to screening 2. Use of non-oral hormonal contraception in the 3 months prior to screening 3. Intention to become pregnant during the study 4. Lactation and/or pregnancy in the previous 6 months prior to screening 5. Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening 6. Depression, BDI-II Beck’s Depression Inventory score (≥) 14 7. Any clinically significant abnormality following review of medical and gynaecological history, clinical laboratory and physical examination and vital signs 8. Contraindications for contraceptive steroids: 9. Use of one or more of the following medications: - Psychoactive drugs - Antihypertensive drugs - Sex steroids other than the current OC - Use at present or within 30 days before start study medication: hydantoins, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, troglitazone, felbamate, rifampicin, rifabutin, griseofulvin, nelfinavir, ritonavir and St. John’s wort (Hypericum perforatum) 10. Administration of any investigational drug within 3 months prior to screening
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E.5 End points |
E.5.1 | Primary end point(s) |
The degree of sexual desire as measured by a single item: ‘To what extent did you feel like having sex in the past 24 hours?’ This is a daily rating included in the Study Diary. |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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) | 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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |