Condition category
Not Applicable
Date applied
13/11/2009
Date assigned
18/12/2009
Last edited
18/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Doris Heger-Mahn

ORCID ID

Contact details

Anklamer Straße 38
Berlin
10115
Germany

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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes