Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function

A Multicenter, Open-label, Randomized, Controlled, Two-arm Study to Assess Compliance With Daily Tablet Intake of Women on Treatment With the Oral Contraceptive SH T00186D/BAY 86-5300 (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function Over 12 Months

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257984

Enrollment

508

Registered

2010-12-10

Start date

2010-12-31

Completion date

2012-09-30

Last updated

2014-10-28

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

Conditions

Contraception

Brief summary

The objective of the study is to evaluate the effect of the dispenser's buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.

Interventions

DRUGBAY86-5300

0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser supported by a reminder function

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection

Exclusion criteria

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) * Body mass index (BMI) \>/= 30.0 kg/m2 * Presence or a history of venous or arterial thrombotic/thromboembolic events * Repeated measurements of systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg. * Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous COC use * Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement * Severe dyslipoproteinemia * Malignant or premalignant disease * Uncontrolled thyroid disorder * Chronic inflammatory bowel disease * Severe renal insufficiency or acute renal failure * History of migraine with focal neurologic symptoms * Epilepsy

Design outcomes

Primary

Measure	Time frame
Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release time	12 months

Secondary

Measure	Time frame
Number of delayed and missed pills	12 months
Bleeding pattern and cycle control parameters	12 months
Length of the tablet break and the length of the bleeding episode preceding the tablet break	12 months

Countries

France, Germany, Italy, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026