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Visanne

Phase 3

Endometriosis | Small molecule | Endocrine |Bayer AG|Last Updated: Jan 9, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment366

FDA Designations

No designations recorded

Clinical trial landscape

Visanne · 2 trials · 1 indication

Phase 3 2
NCT00225186Safety and Efficacy of SH T00660AA in Treatment of EndometriosisEndometriosis
COMPLETED168 Analytics
NCT00225199Efficacy and Safety of SH T00660AA in Treatment of EndometriosisEndometriosis
COMPLETED198 Analytics
PHASE3COMPLETED
Safety and Efficacy of SH T00660AA in Treatment of Endometriosis
EndometriosisUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of SH T00660AA in Treatment of Endometriosis
EndometriosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety assessment of the drug
12-18 months
Efficacy
Assessment of pain relief at end of treatment

Secondary Endpoints

Efficacy (reduction of pelvic pain)
12-18 months
Adverse event collection
Assessment at end of study
Treatment satisfaction by patient
Assessment at end of study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Visanne (SH T00660AA , BAY86-5258)DRUGDaily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients
Visanne (BAY86-5258, SH T00660AA)DRUGorally once daily
PlaceboDRUGorally once daily
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Female patients with endometriosis-associated pelvic pain Exclusion Criteria: * Pregnant or lactating women * History or suspicion of hormone dependent tumor * Therapy resistant endometriosis or need for primary surgical treatment * Any other conditions which forbid the part...

Countries:GermanyItalyUkraine
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Frequently asked questions about Visanne

What is Visanne used for?

Visanne is an investigational small molecule being developed for the treatment of endometriosis. It is currently in Phase 3 clinical development, meaning it has not yet been approved and remains under study. The drug is being evaluated in adult female patients with endometriosis.

Who makes Visanne?

Visanne is being developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. Bayer is conducting the clinical development program for this investigational drug, which is being studied as a treatment for endometriosis.

What phase is Visanne in?

Visanne is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied for the treatment of endometriosis. Two Phase 3 trials have been completed as part of its clinical program.

What clinical trials is Visanne in?

Visanne has been studied in two completed Phase 3 clinical trials: NCT00225186 and NCT00225199. Both trials evaluated the safety and efficacy of the drug in treating endometriosis. The first trial enrolled 168 participants in Germany, Italy, and Ukraine, while the second enrolled 198 participants.

Is Visanne the same as SH T00660AA?

Yes, Visanne is also known as SH T00660AA. The clinical trials for this drug, including NCT00225186 and NCT00225199, use the name SH T00660AA in their titles. Both names refer to the same investigational drug being developed for endometriosis.