Completed

Pearl Index Study With Low Dose Combined Oral Contraceptive

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What is being tested

Minisiston (SH D00342A)

Drug
Who is being recruted

Contraception

From 18 to 40 Years
+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: February 2004

See protocol details

Summary

Principal SponsorBayer
Last updated: April 3, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2004Actual date on which the first participant was enrolled.

The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel. The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official TitleProspective, Multicenter, Open-label, Uncontrolled Study to Investigate the Contraceptive Efficacy, Bleeding Patterns, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 0.125 mg Levonorgestrel (SH D00342A) Applied for 13 Cycles to Healthy Female Volunteers 
Principal SponsorBayer
Last updated: April 3, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
840 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 40 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Contraception
Criteria
1 inclusion criteria required to participate
Healthy women requiring contraception
1 exclusion criteria prevent from participating
Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 25 locations
Suspended
Unknown FacilityHannover, GermanySee the location
Suspended
Unknown FacilityAschersleben, Germany
Suspended
Unknown FacilityBurg, Germany
Suspended
Unknown FacilityEgeln, Germany
Completed25 Study Centers