| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Reduced libido in women with acquired female sexual dysfunction (FSD) associated with oral contraceptive use |
|
| 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 | 10030970 |
| E.1.2 | Term | Oral contraception |
|
| 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 show non-inferiority of SH T00658ID to Microgynon on libido in women with acquired female sexual dysfunction (FSD) associated with OC-use |
|
| E.2.2 | Secondary objectives of the trial |
| The secondary objectives of this study are: Other domains of the FSFI and other self reported measures (Female Sexual Distress Scale (FSDS-R), Psychological General Well-Being Index (PGWBI)) will be evaluated in order to explore further effects of SH T00658ID on female sexual function and general psychological status Clinical Global Impression (CGI) assessment The safety profile of SH T00658ID will be further evaluated Vaginal effects will be evaluated by: vaginal pH measurements, the Atrophy Symptom Questionnaire (ASQ), and the Vaginal Health Assessment (VHA) |
|
| 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 50 years (inclusive), smokers maximum age of 30 years (inclusive) at Visit 1 3- At screening, the subject must be on the OC which has caused the libido complaints according to their perception. All marketed OCs of the monophasic combined oral contraceptive type (COC), including Microgynon, will be allowed. 4- Must be suffering from reduced libido as a perceived side effect of the OC use (ie, acquired OC-associated FSD) for at least three months, but not longer than one year, and willing to switch to the randomly assigned study treatment (SH T00658ID or Microgynon) 5- Value of 18 or below in the not weighted sum score of FSFI sexual desire and sexual arousal component scores, defined as the total of questions 1 to 6 of the FSFI at Screening and Baseline 6- Sexual relationship with a sexually competent partner 7- Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening) |
|
| E.4 | Principal exclusion criteria |
1) Female sexual dysfunction 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) Pregnancy, lactation (at least three cycles have to follow delivery, abortion, or lactation before start of treatment)
4) Body mass index (BMI) >32 kg/m2
5) Hypersensitivity to any of the study drug ingredients
6) Vegetarians/ individuals not consuming pork and beef products. Women may be included if they are willing to take the capsules.
7) Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise)
8) Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results (eg, depression, anxiety, other psychiatric diseases)
9) Any disease or condition that may worsen under hormonal treatment such as eg:
CARDIOVASCULAR presence or a history of venous or arterial thrombotic / thromboembolic events (eg, deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (eg, transient ischaemic attack, angina pectoris) and conditions which could increase the risk to suffer from any of the above mentioned disorders, eg, a family history indicating a hereditary predisposition repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg
LIVER presence or history of liver tumors (benign or malignant) presence or history of severe hepatic disease as long as liver function values have not returned to normal jaundice and / or pruritus related to cholestasis (Gilbert’s syndrome excepted) history of cholestatic jaundice associated with pregnancy or previous COC use
METABOLIC DISEASES uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement severe dyslipoproteinemia
OTHER DISEASES malignant or premalignant disease uncontrolled thyroid disorder chronic inflammatory bowel disease severe renal insufficiency or acute renal failure hemolytic uremic syndrome sickle cell anemia porphyria history of hypertriglyceridemia-associated pancreatitis systemic lupus erythematosus, pemphigoid gestationis during a previous pregnancy Sydenham chorea history of herpes gestationis otosclerosis-related hearing loss history of migraine with focal neurologic symptoms epilepsy clinically significant depression hereditary angioedema
10) Undiagnosed abnormal genital bleeding
11) Abuse of alcohol, drugs, or medicines (eg, laxatives)
12) Other contraceptive methods (see list on paper version)
13) Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results such as: (see list on paper version)
14) Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator
15) Major surgery scheduled for the study period
16) Recent gynecological surgery which might influence sexual activity
17) Subject is a dependent person, eg; a family member or member of the Investigator’s staff
18) Inability to cooperate with the study procedures for any reason, i.e. language comprehension, psychiatric illness, inability to get to the study site |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The 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. |
|
| 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 | 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 | 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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 23 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| 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
|
| Nota alla sezione ``Studio Multicentrico - Paese dove ha luogo il Coordinamento scientifico``: NON E` STATA DESIGNATA A LIVELLO MONDIALE UNA FIGURA CLINICA DI COORDINAMENTO SCIENTIFICO (per l`Italia e` lo Sperimentatore Coordinatore). |
|
| 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 | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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