Influence of Silexan on pharmacokinetics and hormonal activity in females taking oral contraceptives

ISRCTN ISRCTN52706881
DOI https://doi.org/10.1186/ISRCTN52706881
Secondary identifying numbers 750201.01.019
Submission date
13/11/2009
Registration date
18/12/2009
Last edited
18/12/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Doris Heger-Mahn
Scientific

Anklamer Straße 38
Berlin
10115
Germany

Study information

Study designSingle centre double-blind randomised placebo-controlled cross-over study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDouble-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
Study objectivesThe 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(s)Ethik-Kommission des Landes Berlin approved on the 12th October 2009 (ref: ZS EK 12 432/09)
Health condition(s) or problem(s) studiedPharmacokinetics of ethinyl estradiol and levonorgestrel
InterventionOne capsule with 160 mg Silexan or placebo respectively per day in the morning for 2 times 28 days (56 consecutive days).
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)Ethinyl estradiol, levonorgestrel, Silexan (WS®1265)
Primary outcome measurePlasma levonorgestrel and ethinyl estradiol: AUCtau, at the PK profile days over 24 hours at day 19, 20 or 21 of the cycle.
Secondary outcome measures1. 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 study start date01/12/2009
Completion date31/05/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants24
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2009
Date of final enrolment31/05/2010

Locations

Countries of recruitment

  • Germany

Study participating centre

Anklamer Straße 38
Berlin
10115
Germany

Sponsor information

Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry

Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany

ROR logo "ROR" https://ror.org/043rrkc78

Funders

Funder type

Industry

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan