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Gynodian Depot

Phase 3

Hormone Replacement Therapy | Small molecule | Other |Bayer AG|Last Updated: Dec 30, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

Gynodian Depot · 1 trial · 1 indication

Phase 3 1
NCT00463450Efficacy of Gynodian® Depot in Women With Impaired Well-beingHormone Replacement Therapy
COMPLETED140 Analytics
PHASE3COMPLETED
Efficacy of Gynodian® Depot in Women With Impaired Well-being
Hormone Replacement Therapy
NCT00463450140
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Study Endpoints

Primary Endpoints

To assess the difference in the Global Severity Index (GSI) of both treatment sequences with Gynodian Depot and with estradiol valerate
After 4.5 cycles of treatment

Secondary Endpoints

To assess the difference in the GSI in both treatment sequences
After 1.5 cycles of treatment
To assess the difference in the scores of the psychometric tests and rating scales SCL-90-R, Menopause rating scale, HADS and Visual analog Scale in both treatment sequences
After 1.5 and 4.5 cycles of treatment
To assess serum hormone levels of DHEA, DHEAS, androsterone, testosterone, dihydrotestosterone, androstenediol-glucuronid, estradiol, estrone, and SHBG
At end of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Gynodian® Depot (BAY86-5032)DRUGInjection monthly
BAY86-4980DRUGorally
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Eligibility Criteria

Age Range45 Years to 65 Years
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Written informed consent * Postmenopausal status (amenorrhea for at least 12 months) * 45 - 65 years of age * Application of estrogen or cyclic estrogen/progestin preparation other than the study medication for at least 6 months prior to Visit 1 * Relevant impairment of well-b...

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Frequently asked questions about Gynodian Depot

What is Gynodian Depot used for?

Gynodian Depot is used for hormone replacement therapy in women. It is an investigational small molecule being developed by Bayer AG. The drug is currently in Phase 3 clinical development, and it has been studied in a completed clinical trial for its efficacy in women with impaired well-being.

Who makes Gynodian Depot?

Gynodian Depot is developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is an investigational small molecule intended for hormone replacement therapy. It is currently in Phase 3 clinical development, with one completed clinical trial.

What phase is Gynodian Depot in?

Gynodian Depot is in Phase 3 clinical development. It is an investigational drug for hormone replacement therapy, developed by Bayer AG. The drug has completed one Phase 3 trial, and it is not yet approved by regulatory authorities.

What clinical trials is Gynodian Depot in?

Gynodian Depot has been studied in a completed Phase 3 clinical trial with the identifier NCT00463450. The trial, titled 'Efficacy of Gynodian® Depot in Women With Impaired Well-being,' enrolled 140 female participants aged 45 years and older. The trial was randomized, double-blind, and active-controlled.

Is Gynodian Depot the same as Gynodian?

Gynodian Depot is a specific formulation of the drug Gynodian, as indicated by the 'Depot' suffix, which typically denotes a prolonged-release formulation. The drug is developed by Bayer AG for hormone replacement therapy and is currently in Phase 3 clinical development.