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
Scientific
Anklamer Straße 38
Berlin
10115
Germany
Study information
| Study design | Single centre double-blind randomised placebo-controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Ethik-Kommission des Landes Berlin approved on the 12th October 2009 (ref: ZS EK 12 432/09) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2009 |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 24 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2009 |
| Date of final enrolment | 31/05/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
Anklamer Straße 38
Berlin
10115
Germany
10115
Germany
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
