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Minisiston

Phase 3

Contraception | Small molecule | Endocrine |Bayer AG|Last Updated: Apr 3, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment840

FDA Designations

No designations recorded

Clinical trial landscape

Minisiston · 1 trial · 1 indication

Phase 3 1
NCT00220324Pearl Index Study With Low Dose Combined Oral ContraceptiveContraception
COMPLETED840 Analytics
PHASE3COMPLETED
Pearl Index Study With Low Dose Combined Oral Contraceptive
ContraceptionUnlock trial analytics

Study Endpoints

Primary Endpoints

Unadjusted Pearl Index
After 13 cycles of intake

Secondary Endpoints

Adjusted Pearl Index
After 13 cycles of intake
Cumulative pregnancy rate
After 13 cycles of intake
Bleeding pattern
After 13 cycles of intake
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
Minisiston (SH D00342A)DRUGDaily oral administration in 21 days per cycle, followed by a 7-day pill-free interval
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Eligibility Criteria

Age Range18 Years to 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites25

Inclusion Criteria: * Healthy women requiring contraception Exclusion Criteria: * Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.

Countries:Germany
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Frequently asked questions about Minisiston

What is Minisiston used for?

Minisiston is a small molecule drug used for contraception. It is a low dose combined oral contraceptive being developed by Bayer AG. The drug is intended for use in women aged 18 years and older, as studied in a clinical trial conducted in Germany.

Who makes Minisiston?

Minisiston is being developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is currently in Phase 3 clinical development for contraception, with one completed trial involving 840 participants.

What phase is Minisiston in?

Minisiston is in Phase 3 clinical development. It is an investigational drug for contraception and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug remains under clinical investigation.

What clinical trials is Minisiston in?

Minisiston has one completed Phase 3 clinical trial registered under NCT00220324, titled "Pearl Index Study With Low Dose Combined Oral Contraceptive." The trial enrolled 840 healthy female volunteers aged 18 years and older in Germany, studying the drug for contraception.

Is Minisiston the same as a low dose combined oral contraceptive?

Minisiston is a low dose combined oral contraceptive, as indicated by the clinical trial title. It is a small molecule drug being developed for contraception, and the completed Phase 3 study evaluated its Pearl Index, a measure of contraceptive effectiveness.