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Minisiston

Phase 3

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

Minisiston target and mechanism

ModalitySmall molecule

Also known as Minisiston (SH D00342A)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment840

FDA Designations

No designations recorded

Minisiston clinical trials

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 low dose combined oral contraceptive used for contraception in women. It is being developed by Bayer AG and has been studied in a Phase 3 Pearl Index trial in Germany. The study enrolled 840 healthy female volunteers aged 18 years and older.

Who makes Minisiston?

Minisiston is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor behind the clinical development program for this low dose combined oral contraceptive, including the Phase 3 Pearl Index study conducted in Germany.

What phase is Minisiston in?

Minisiston is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The completed study was an uncontrolled Pearl Index study of the low dose combined oral contraceptive, with no randomized or double-blind design.

What clinical trials is Minisiston in?

Minisiston has been evaluated in one completed Phase 3 trial, NCT00220324, titled Pearl Index Study With Low Dose Combined Oral Contraceptive. The study enrolled 840 healthy female volunteers aged 18 years and older in Germany and assessed contraception.

Is Minisiston the same as Minisiston (SH D00342A)?

Yes, Minisiston is also known as Minisiston (SH D00342A). Both names refer to the same low dose combined oral contraceptive developed by Bayer AG for contraception, studied in the completed Phase 3 Pearl Index trial NCT00220324.