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Micronised Progesterone

Phase 3

Infertility | Small molecule | Other |Merck KGaA|Trials Updated: Jul 31, 2014

Micronised Progesterone development status

Highest phase Phase 3
Registered trials 3 across 3 sponsors since Jan 2010

Micronised Progesterone target and mechanism

ModalitySmall molecule

Also known as Crinone 8%

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment238

FDA Designations

No designations recorded

Micronised Progesterone clinical trials

Micronised Progesterone · 1 trial · 1 indication

Phase 3 1
NCT01081652A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)Infertility
COMPLETED238 Analytics
PHASE3COMPLETED
A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)
Infertility
NCT01081652238
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Study Endpoints

Primary Endpoints

The difference in hCG positive rate in the two arms 14 days after embryo transfer
The difference in pregnancy rates in the two arms 30 and 60 days after embryo transfer
The difference in implantation rate in the two arms 30 days after embryo transfer
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Crinone 8% groupEXPERIMENTALFemale subjects undergoing IVF/ET treated with Crinone 8% intravaginally
Intramuscular progesterone groupACTIVE_COMPARATORFemale subjects undergoing IVF/ET treated with 60 mg progesterone intramuscularly once daily

Interventions

NameTypeDescription
Micronised ProgesteroneDRUGMicronised progesterone administered intravaginally once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.
ProgesteroneDRUGProgesterone 60 mg administered intramuscular once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.
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Eligibility Criteria

SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patient has given written informed consent * BMI \< 25 kg/m2 * Age \< 36 years * \<3 prior ART cycles (IVF, ICSI and related procedures) * Infertility * Regular spontaneous ovulatory menstrual cycles Exclusion Criteria: * Habitual abortion * Hydrosalpinges * History of past ...

Countries:China
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