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Dehydroepiandrosterone, BAY86-5314

Phase 2

Libido | Small molecule | Other |Bayer AG|Last Updated: Dec 2, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Dehydroepiandrosterone, BAY86-5314 · 1 trial · 1 indication

Phase 2 1
NCT00566384Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptives in Women Complaining of Reduced LibidoLibido
COMPLETED100 Analytics
PHASE2COMPLETED
Efficacy and Safety of Oral Dehydroepiandrosterone as a Concomitant Therapy to Oral Contraceptives in Women Complaining of Reduced Libido
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Study Endpoints

Primary Endpoints

FSDS questionnaire (sexual desire and arousal component scores)
at baseline and after Cycle 6

Secondary Endpoints

Change from baseline period to cycle 6 in the number of satisfactory sexual events
after Cycle 6
FSFI questionnaire (absolute values and change from baseline) - All domains
Cycle 1, 3, 6 and follow-up
FSDS-R questionnaire results
Cycle 1, 3, 6 and follow-up
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Dehydroepiandrosterone, BAY86-5314DRUGTreatment with daily oral intake of two capsules containing 50 mg DHEA each. Treatment duration will be 24 weeks
PlaceboDRUGTreatment with daily oral intake of two capsules containing Placebo. Treatment duration will be 24 weeks
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Treatment with a oral contraceptive (OC) for at least 3 months and willing to continue the OC * Loss of libido * Sexual relationship with a sexually competent partner Exclusion Criteria: * Female sexual dysfunction other than HSDD, arousal and orgasmic disorder, such as sexu...

Countries:Germany
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Frequently asked questions about Dehydroepiandrosterone, BAY86-5314

What is Dehydroepiandrosterone (BAY86-5314) used for?

Dehydroepiandrosterone (BAY86-5314) is an investigational small molecule being studied for the treatment of reduced libido in women. It is being developed as an oral therapy to be used as a concomitant treatment with oral contraceptives. The drug is currently in Phase 2 clinical development.

Who makes Dehydroepiandrosterone (BAY86-5314)?

Dehydroepiandrosterone (BAY86-5314) is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical trials to evaluate the drug's efficacy and safety for treating reduced libido.

What phase is Dehydroepiandrosterone (BAY86-5314) in?

Dehydroepiandrosterone (BAY86-5314) is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its potential to treat reduced libido in women who are also taking oral contraceptives.

What clinical trials is Dehydroepiandrosterone (BAY86-5314) in?

Dehydroepiandrosterone (BAY86-5314) has one completed Phase 2 clinical trial registered as NCT00566384. This trial was a randomized, double-blind, placebo-controlled study that enrolled 100 female participants in Germany. The study evaluated the efficacy and safety of oral dehydroepiandrosterone as a concomitant therapy to oral contraceptives in women with reduced libido.

Is Dehydroepiandrosterone (BAY86-5314) the same as DHEA?

Dehydroepiandrosterone (BAY86-5314) is also known as DHEA, a common abbreviation for the compound. In clinical trials, it is referred to as dehydroepiandrosterone. The drug is being investigated by Bayer AG for its potential role in improving libido in women using oral contraceptives.