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.

Phase 1

• 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; MedDRA version: 12.0Level: LLTClassification code 10021926Term: Infertility; MedDRA version: 12.0Level: LLTClassification code 10056204Term: In vitro fertilisation

• Registration Number: EUCTR2010-020559-29-CZ
• Lead Sponsor: Pantec Biosolutions AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-12
• Last Update Posted: 21 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 20

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.
11.Normal endocrine status.
12.Having normal ovaries as confirmed with ultrasound.
13.Subjects having a normal skin without excessive hair growth on application areas.
14.Normal duration of menstrual cycle of 28 +/- 2 days.
15.Non-smoker.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
11.Medical history or known risk of thrombosis.
12.Medical history or current ovarian enlargement, or vaginal bleeding.
13.Any visible skin disorder, dermatologic disease or abnormal skin pigmentation, which, in the opinion of the investigator, would interfere with the outcome of the study.
14.Vegetarians.
15.Blood donation within 30 days prior to inclusion in this study.
16.Participation in the treatment phase of a clinical study within 30 days prior to the treatment phase of this study.
17.Laboratory values outside the reference range that are of clinical relevance (e.g., suggesting an unknown disease and requiring further clinical evaluation assessed by the investigator) especially aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (gamma-GT).
18.Positive test for human immunodeficiency virus (HIV) antibodies.
19.Positive Hepatitis B-virus surface antigen (HBsAg) test.
20.Positive Anti-hepatitis C-virus antibodies (Anti-HCV) test.
21.Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis abuse (verified by Mahsan Kombi/DOA2- and Mahsan Kombi4/O2T Schnelltest).
22.Ethanol consumption within 24 h prior to first administration of FSH, verified by alcohol breath test.
23.Consumption of xanthine-containing food or beverages within 24 h prior to first administration of FSH.
24.Any gastrointestinal complaints within seven days prior to dosing.
25.Use of any medication (self-medication or prescription medication) within four weeks prior to Day 1 of stimulation period (or at least 10 times the respective elimination half-life, whichever is longer).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This proof-of-concept study will 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 subcutaneously administered urofollitropin.;Secondary Objective: ;Primary end point(s): AUC0-t, Cmax, and tmax