Recent Updates
Recently added Catalysts

Micronised Progesterone

Phase 3

Infertility | Small molecule | Other |Merck & Company, Inc.|Last Updated: Jul 31, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment238

FDA Designations

No designations recorded

Clinical trial landscape

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)
InfertilityUnlock trial analytics

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Micronised Progesterone

What is Micronised Progesterone used for?

Micronised Progesterone is used for infertility, specifically as luteal phase support in women undergoing in vitro fertilisation (IVF) and embryo transfer (ET). It is a small molecule being developed by Merck & Company, Inc. (MRK) and is currently in Phase 3 clinical development.

Who makes Micronised Progesterone?

Micronised Progesterone is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's use in infertility treatment.

What phase is Micronised Progesterone in?

Micronised Progesterone is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with a total enrollment of 238 participants.

What clinical trials is Micronised Progesterone in?

Micronised Progesterone has one completed Phase 3 trial, identified as NCT01081652. The study evaluated the drug (Crinone 8%) for luteal phase support in women undergoing IVF and embryo transfer in China. The trial enrolled 238 female participants and was actively controlled.

Is Micronised Progesterone the same as Crinone?

Yes, Micronised Progesterone is also known as Crinone 8%. The Phase 3 clinical trial NCT01081652 used the brand name Crinone 8% to refer to the drug being studied for luteal phase support in infertility treatment.