SMP-028/Oral Contraceptive Drug: Drug Interaction study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93391015

Enrollment

Registered

2010-01-19

Start date

2010-01-14

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Respiratory Asthma

Interventions

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 day

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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, ?Z, 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.	—

Measure

Time frame

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, ?Z, 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.

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026