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ContraceptionPhase 3NCT01257984

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

A Phase 3 study testing BAY86-5300 in people with Contraception, run by Bayer at 43 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
BAY86-5300
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
508 participants
Where
43 sitesin 5 countries
Study dates
Dec 2010to Sep 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

43 sites in 5 countries.

43 sites in 5 countries

Italy12 sites

  • Study site

    Bologna, 40138

  • Study site

    Brescia, 25123

  • Study site

    Cagliari, 09124

  • Study site

    Catania, 95123

  • Study site

    Milan, 20154

  • Study site

    Modena, 41124

  • Study site

    Naples, 80138

  • Study site

    Palermo, 90127

  • Study site

    Pavia, 27100

  • Study site

    Pisa, 56126

  • Study site

    Roma, 00189

  • Study site

    Siena, 53100

Other trials in Italy

France10 sites

  • Study site

    Biarritz, 64200

  • Study site

    Marly-le-Roi, 78160

  • Study site

    Nancy, 54000

  • Study site

    Olivet, 45160

  • Study site

    Paris, Paris, 75018

  • Study site

    Paris, 75 009

  • Study site

    Paris, 75 017

  • Study site

    Paris, 75007

  • Study site

    Strasbourg, 67 000

  • Study site

    Toulouse, 31000

Other trials in France

Germany9 sites

  • Study site

    Blankenburg, Saxony-Anhalt, 38889

  • Study site

    Burg, Saxony-Anhalt, 39288

  • Study site

    Frankfurt am Main, Hesse, 60590

  • Study site

    Gera, Thuringia, 07545

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20357

  • Study site

    Heidelberg, Baden-Wurttemberg, 69115

  • Study site

    Kahla, Thuringia, 07768

  • Study site

    Magdeburg, Saxony-Anhalt, 39130

  • Study site

    Wuppertal, North Rhine-Westphalia, 42103

Other trials in Germany

United Kingdom7 sites

  • Study site

    Bath, Somerset, BA1 2SR

  • Study site

    Bradford on Avon, Wiltshire, BA15 1DQ

  • Study site

    Cardiff, CF5 4AD

  • Study site

    Chesterfield, Derbyshire, S40 4TF

  • Study site

    Corsham, Wiltshire, SN3 9DL

  • Study site

    East Horsley, Surrey, KT24 6QT

  • Study site

    Nottingham, Nottinghamshire, NG2 4PJ

Other trials in United Kingdom

Spain5 sites

  • Study site

    Barcelona, Barcelona, 08019

  • Study site

    Boadilla del Monte, Madrid, 28660

  • Study site

    Córdoba, Córdoba, 14004

  • Study site

    Elda, Alicante, 03600

  • Study site

    Málaga, Málaga, 29013

Other trials in Spain

About this study

Official title: 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

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.

Conditions
Contraception
Being tested
BAY86-5300

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY86-5300Drug

    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

  • BAY86-5300Drug

    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 without reminder support

Study groups in NCT01257984
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: BAY86-5300
Arm 2ExperimentalNot described
Receives: Drug: BAY86-5300

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release time

    Measured: 12 months

Secondary outcomes (3)

  1. Number of delayed and missed pills

    Measured: 12 months

  2. Bleeding pattern and cycle control parameters

    Measured: 12 months

  3. Length of the tablet break and the length of the bleeding episode preceding the tablet break

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionAug 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01257984
Sponsor's protocol ID
14701
Other IDs
2010-019902-17
Status last verified
Oct 2014
First submitted
9 Dec 2010
Last updated
28 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BAY86-5300 in people with Contraception, run by Bayer at 43 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Italy, France, Germany, United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release time (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01257984.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.

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