Condition category
Respiratory
Date applied
04/01/2010
Date assigned
19/01/2010
Last edited
21/05/2010
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 Noreen O'Connor

ORCID ID

Contact details

Dainippon Sumitomo Pharma Europe Ltd
1st Floor
Southside
97 - 105 Victoria Street
London
SW1E 6QT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D4050158

Study information

Scientific title

A randomised, double-blind, placebo-controlled, two-sequence, two-period, crossover study to evaluate the effect of SMP-028 on oral contraceptive pharmacokinetics in healthy female subjects

Acronym

OC-DDI

Study hypothesis

Primary:
To evaluate the effect of co-administration of SMP-028 on the pharmacokinetic (PK) profile of Microgynon 30®.

Secondary:
1. To evaluate the PK profile of SMP-028 in healthy female subjects taking Microgynon 30®
2. To evaluate the effect of co-administration of SMP-028 on the pharmacodynamic (PD) response to Microgynon 30®
3. To assess the safety and tolerability of co-administration of SMP-028 and Microgynon 30® in healthy female subjects

Ethics approval

Added 21/05/10:
The Independent Ethics Committee of the Foundation “Evaluation of Ethics in Biomedical Research” Assen approved on the 11th of January 2010 (ref: D4050158 [OC-DDI])

Study design

Randomised double-blind placebo-controlled two-sequence two-period crossover 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 subject information sheet

Condition

Asthma

Intervention

Subjects will receive Microgynon 30® (or another brand of the OC pill containing equivalent components) during a 2 cycle synchronisation period. Subjects will continue to receive Microgynon 30® on days 1 to 21 of both treatment periods. Subjects will also receive either SMP-028 (160 mg) once daily or matching placebo on Days 1 to 21 of each treatment period. Each subject will receive SMP-028 for one treatment period, placebo for the other treatment period.

Intervention type

Drug

Phase

Phase I

Drug names

SMP-028, Microgynon 30®

Primary outcome measures

1. Pharmacokinetics: Drug exposure of the components of Microgynon 30® (ethinylestradiol [EE] and levonorgestrel [LNG]) as measured by serum AUC0-tlast and Cmax of EE and LNG on day 21
2. Pharmcodynamics:
2.1. Clotting times (e.g. prothrombin and activated partial thromboplastin times) measured at day 21
2.2. Maximum follicular diameter at day 21
2.3. Serum oestradiol, FSH, LH and progesterone levels taken at day 14 and 21
2.4. Sex hormone binding globulin (SHBG) at day 21

Secondary outcome measures

1. Pharmacokinetics:
1.1. Drug exposure of SMP-028 as measured by serum AUC0-tlast, and Cmax on day 21
1.2. Other PK parameters including Tmax, AUC0-8, λZ, t1/2, MRT, CL/F and Vz/F for SMP-028, EE and LNG on day 21
2. Safety endpoints:
2.1. Incidence and severity of adverse events (AEs)
2.2. Discontinuations due to AEs
2.3. Actual values and changes in values from baseline in standard laboratory safety tests, vital signs, physical examinations and 12-lead ECGs (electrocardiograms)

Subjects will be provided with subject diary to record timing of OC intake and details of vaginal bleeding.

Overall trial start date

14/01/2010

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy female subjects aged 18 to 45 years
2. In good health as determined by:
2.1. Past medical history
2.2. Physical examination
2.3. Electrocardiogram
2.4. Clinical safety laboratory tests
2.5. Urinalysis

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

22 healthy female subjects (11 in each group). In order to obtain 22 completers, it is estimated that 30 subjects will be enrolled.

Participant exclusion criteria

1. Contraindications to the administration of a combined oral contraceptive (OC) pill
2. Other standard exclusion criteria

Recruitment start date

14/01/2010

Recruitment end date

30/06/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dainippon Sumitomo Pharma Europe Ltd
London
SW1E 6QT
United Kingdom

Sponsor information

Organisation

Dainippon Sumitomo Pharma Europe Ltd (UK)

Sponsor details

c/o Noreen O'Connor
PhD
1st Floor
Southside
97 - 105 Victoria Street
London
SW1E 6QT
United Kingdom

Sponsor type

Industry

Website

http://www.ds-pharma.co.jp/english

Funders

Funder type

Industry

Funder name

Dainippon Sumitomo Pharma Co. Ltd (Japan)

Alternative name(s)

Dainippon Sumitomo Pharma Co., Ltd.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Japan

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