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BAY86-4891

Phase 2

Contraception | Small molecule | Endocrine |Bayer AG|Last Updated: Dec 2, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

BAY86-4891 · 1 trial · 1 indication

Phase 2 1
NCT00631124A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment CyclesContraception
COMPLETED103 Analytics
PHASE2COMPLETED
A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles
Contraception
NCT00631124103
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Study Endpoints

Primary Endpoints

The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no
12 months

Secondary Endpoints

Assessment of ovarian activity in treatment cycles 2 and 3
12 months
Course of gonadotropins (FSH, LH)
12 months
Endometrial growth
12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
BAY86-4891 (Estradiol / Drospirenone)DRUGMonophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy female volunteers, * Age 18 - 35 years Exclusion Criteria: * Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease) * Regular intake of medication * Clinically relevant findings (ECG, bloo...

Countries:Germany
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Frequently asked questions about BAY86-4891

What is BAY86-4891 used for?

BAY86-4891 is an investigational small molecule being developed for contraception. It is an oral estrogen/progestogen regimen studied in healthy, young females to evaluate inhibition of ovulation over three treatment cycles. The drug is in Phase 2 clinical development and is not yet approved.

Who makes BAY86-4891?

BAY86-4891 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the drug's safety and efficacy for contraception.

What phase is BAY86-4891 in?

BAY86-4891 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for use in contraception, with one completed Phase 2 trial involving 103 participants.

What clinical trials is BAY86-4891 in?

BAY86-4891 has one completed clinical trial, registered as NCT00631124. This Phase 2 study evaluated inhibition of ovulation of two oral estrogen/progestogen regimens in healthy, young females over three treatment cycles. The trial was conducted in Germany, enrolled 103 participants, and was randomized, double-blind, and controlled.

Is BAY86-4891 the same as other contraceptive drugs?

BAY86-4891 is a specific investigational drug developed by Bayer AG. It is an oral estrogen/progestogen combination studied for contraception. No alternative names for BAY86-4891 have been identified in the available clinical trial information.