Pilot clinical study on the systemic bioavailability of l-thyroxine in healthy female volunteers after four weeks of topical treatment with a new formulation based on l-thyroxine - SOMA-001-2010

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10065339Term: CelluliteSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; treatment of localized fat, accompanied by cellulite; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2010-023918-30-IT
• Lead Sponsor: SOCIETA' ITALO BRITANNICA L. MANETTI - H.ROBERTS & C. PER AZIONI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-05
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. Adult women aged between 18 and 50 years.
2. Caucasians.
3. BMI (Body Mass Index) <30.
4. Blood pressure, measured in the supine position after 5 minutes rest, less than or equal to 90 mm / Hg and 140 mm / Hg respectively for systolic and diastolic.
5. Heart rate measured in the supine position after 5 minutes of rest between 50 and 90 beats / minute.
6. Signing the informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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. Pregnancy or breast-feeding in place.
2. Changes (early or suspension) of the use of contraceptive estrogen-progestin in the last 4 weeks.
3. Inability to take adequate contraception during the study.
4. Any disease or dysfunction, even asymptomatic, significant endocrine disruption and thyroid in particular.
5. Any acute or chronic detectable load of any device on history.
6. Any clinically significant abnormality detected on examination.
7. Any clinically significant abnormality detectable on ECG.
8. Any clinically significant abnormal laboratory values.
9. History of allergy or intolerance to study the products and / or excipients.
10. Over the past 6 months, treatment or therapeutic use of iodine or iodine-containing medications (eg amiodarone, Somatoline).
11. Over the past 6 months, treatment with antithyroid drugs.
12. Over the past 6 months, diagnostic tests that led to the use of tracers, contrast agents containing iodine or iodine isotopes.
13. During the past 4 weeks, changes in diet of foods containing iodine (eg iodized salt), or use disinfectants (eg Betadine), detergents or any systemic or topical product containing iodine, including mouthwashes (eg Iodosan), toothpaste iodinated, douches, Lugol's solution.
14. Alcohol abuse (over 75 g / day of ethanol), xanthine (over 5 cups / day), tobacco (over 10 cigarettes / day) or use of psychotropic drugs (except for occasional use as ipnoinuttori) or any drug.
15. Donate blood or bleeding in the previous three months, or intentions to donate blood during the study and 4 weeks later.
16. Persons unable to psychological or linguistic reasons, to understand the information given to obtain the consent or who refuse to give consent in writing.
17. Another clinical study in the four weeks prior to or during this study or are planning to take part in a study with experimental drugs during the current surve

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the systemic bioavailability of l-thyroxine (FT4) in healthy women after application of a new formulation of Somatoline dosing schedules provided by the AIC;Secondary Objective: Evaluation of the systemic bioavailability of T3, rT3 and TSH under the same conditions specified in the primary endpoint.<br>Evaluation of the safety and tolerability of systemic and local product.;Primary end point(s): evaluation on healthy adult women of the stability compared to pre-treatment plasma concentrations of l-thyroxine (FT4) observed 5:24 hours and after 14 days and 28 days after the first use of a new formulation of Somatoline applied in accordance SmPC the terms of the product