EUCTR2010-020559-29-CZ
Active, not recruiting
Phase 1
Proof of concept study to investigate the efficacy, safety and tolerability as well as the pharmacokinetics and pharmacodynamics of a newly developed patch containing follicle-stimulating hormone applied after laser poration of the skin in oocyte donors compared to standard stimulation with intramuscularly/subcutaneously administered urofollitropin.A single-center, multiple dose, open label proof of concept study.
ConditionsHealthy female oocyte donors of normal body weight (body mass index within 18 to 29 kg/m2), age from 20 to 30 years (inclusive), ultrasound of ovaries, normal endocrine status, non-smokerMedDRA version: 12.0Level: LLTClassification code 10021926Term: InfertilityMedDRA version: 12.0Level: LLTClassification code 10056204Term: In vitro fertilisation
DrugsFostimon
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy female oocyte donors of normal body weight (body mass index within 18 to 29 kg/m2), age from 20 to 30 years (inclusive), ultrasound of ovaries, normal endocrine status, non-smoker
- Sponsor
- Pantec Biosolutions AG
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects who are able to understand and follow instructions during the study.
- •2\.Signed informed consent.
- •3\.Female Caucasians between 20 and 30 years (inclusive) of age in general good physical health as determined by medical history, physical examination, 12 lead electrocardiogram (ECG), vital signs, and clinical laboratory tests.
- •4\.Weight within the normal range according to accepted values for the Body mass index (BMI) within 18\-29 kg/m2\.
- •5\.Oocyte donors.
- •6\.Normal blood pressure (systolic blood pressure equal to or greater than 90, equal to or lower than 139 mmHg; diastolic blood pressure equal to or greater than 55, equal to or lower than 89 mmHg) measured after 5 min rest in supine position.
- •7\.A pulse rate at rest of equal to or greater than 45 and equal to or lower than 99 bpm measured after 5 min rest in supine position.
- •8\.ECG recording without clinically significant abnormalities.
- •9\.Having had no febrile or infectious illness for at least seven days prior to the first administration of the investigational medicinal products of the study.
- •10\.Normal progesterone levels.
Exclusion Criteria
- •1\.Demonstrating excess in xanthine consumption (more than five cups of coffee or equivalent per day).
- •2\.More than moderate alcohol consumption (\>35 g of ethanol regularly per day or \>245 g regularly per week).
- •3\.Any history of alcohol or drug abuse
- •4\.Demonstrating any active physical disease, acute or chronic
- •5\.Any history of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis as well as current hay fever.
- •6\.Any history of hypersensitivity to the investigational medicinal product or the run\-in treatment.
- •7\.Any history of chronic gastritis or peptic ulcers.
- •8\.Any history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological (esp. history of epileptic seizures), endocrinological, immunological, psychiatric or cardiovascular disease, myopathies, and bleeding tendency.
- •9\.Subject with polycystic ovarian disease.
- •10\.Medical history or current tumors of the pituary gland, hypothalamus, breast, uterus or ovary.
Outcomes
Primary Outcomes
Not specified
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