Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
750201.01.019
Study information
Scientific title
Double-blind, placebo-controlled, randomised, cross-over study to evaluate the interacting influence of 160 mg Silexan (WS®1265) on pharmacokinetics, and hormonal and ovarian activity in 24 healthy females taking an oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel
Acronym
Study hypothesis
The objective of the study is to assess the interacting potential of 160 mg once daily administration of Silexan on the pharmacokinetics of ethinyl estradiol and levonorgestrel.
Ethics approval
Ethik-Kommission des Landes Berlin approved on the 12th October 2009 (ref: ZS EK 12 432/09)
Study design
Single centre double-blind randomised placebo-controlled cross-over study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pharmacokinetics of ethinyl estradiol and levonorgestrel
Intervention
One capsule with 160 mg Silexan or placebo respectively per day in the morning for 2 times 28 days (56 consecutive days).
Intervention type
Drug
Phase
Phase I
Drug names
Ethinyl estradiol, levonorgestrel, Silexan (WS®1265)
Primary outcome measure
Plasma levonorgestrel and ethinyl estradiol: AUCtau, at the PK profile days over 24 hours at day 19, 20 or 21 of the cycle.
Secondary outcome measures
1. Hoogland score assessments at day 28 of the cycle
2. Cmax and tmax of levonorgestrel and ethinyl estradiol profiles, assessed over 24 hours at day 19, 20 or 21 of the cycle
3. Safety and tolerability
Overall trial start date
01/12/2009
Overall trial end date
31/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 - 38 years
2. Signed informed consent
3. Healthy female volunteer
4. Body mass index between 18 and 30 kg/m^2
5. At least 3 months since delivery, abortion, or lactation before randomisation
6. Willingness to use non-hormonal methods of contraception
7. Subjects must have taken oral contraceptive for at least two cycles before start of the first treatment cycle
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
24
Participant exclusion criteria
1. Pregnancy, a repeatedly positive urine pregnancy test or lactation
2. Known or suspected malign tumours or history thereof
3. Thrombophlebitis, venous or arterial thromboembolic diseases (thrombosis, pulmonary embolism, stroke or myocardial infarction) or other conditions that increase susceptibility to thromboembolic diseases
4. Known or suspected benign tumours of the liver, pituitary and adrenal gland or history thereof
5. Known or suspected liver disorders, diabetes mellitus, pancreatitis or a history thereof if associated with severe hypertriglycidemia or disturbances of lipid metabolism, kidney disease with impaired renal function
6. Gastrointestinal disorders with uncertain absorption of orally administered drugs
7. Known allergy to lavender oil or other ingredients of the investigational drug
8. History of migraine with neurological symptoms
9. Clinically significant depression (current or during the last year)
10. Any known diseases or conditions that compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
11. Any known severe systemic disease that might interfere with the conduct of the study or the interpretation of the results
12. Clinically relevant deviations from screened laboratory parameters
13. Sickle-cell anaemia
14. Epilepsy
15. Alcohol, drug, or medicine abuse or suspicion thereof
16. Donation of blood or plasmapheresis after signing the informed consent
17. Regular intake of the following medication:
17.1. Any drugs that might interfere with the study objectives especially any drugs known to induce liver enzymes
17.2. Any drugs known to inhibit CYP3A4
17.3. Any broad-spectrum antibiotics, long-acting injectable or implant hormonal therapy within 26 weeks prior to the screening phase
17.4. Any continuous combined oral contraceptive (COC) intake regimen after screening
Recruitment start date
01/12/2009
Recruitment end date
31/05/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Anklamer Straße 38
Berlin
10115
Germany
Funders
Funder type
Industry
Funder name
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list