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ulipristal

Phase 1

Contraception | Small molecule | Endocrine |Merck & Company, Inc.|Last Updated: Jul 12, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

ulipristal · 1 trial · 1 indication

Early Phase 1 1
NCT04291001Ovarian Function With ENG Implant and UPA UseContraception
COMPLETED40 Analytics
EARLY_PHASE1COMPLETED
Ovarian Function With ENG Implant and UPA Use
ContraceptionUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Ovulation With Implant-alone
5 days

Ovulation will be monitored by ultrasound and serum LH and progesterone levels

Number of Participants With Ovulation With Implant and Same Day UPA
5 days

Ovulation will be monitored by ultrasound and serum LH and progesterone levels

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
ENG Implant aloneACTIVE_COMPARATORParticipants will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.
ENG Implant plus oral UPAACTIVE_COMPARATORParticipants will receive a contraceptive implant and oral UPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.

Interventions

NameTypeDescription
ENG implantDEVICEThis is an FDA-approved contraceptive device
oral ulipristal acetateDRUGThis is an FDA-approved oral emergency contraceptive
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Healthy females, age 18-35 * Fluent in English * BMI \< 30 kg/m2 * No known contraindication to either the ENG contraceptive implant or Ulipristal Acetate (UPA) using the CDC Medical Eligibility Criteria for Contraceptive Use 2016 * Not current pregnant and not at risk of preg...

Countries:United States
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Frequently asked questions about ulipristal

What is ulipristal used for?

Ulipristal is an investigational small molecule being studied for contraception. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 clinical development. The drug is intended for use in females aged 18 years and older.

Who makes ulipristal?

Ulipristal is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for contraception.

What phase is ulipristal in?

Ulipristal is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One early Phase 1 trial has been completed, and the drug is not currently in any active clinical trials.

What clinical trials is ulipristal in?

Ulipristal has one completed clinical trial, NCT04291001, titled "Ovarian Function With ENG Implant and UPA Use." This early Phase 1 study enrolled 40 female participants in the United States and was active-controlled, though it was not double-blinded.

Does ulipristal have any alternative names?

Ulipristal is also known by the abbreviation UPA, which was used in the clinical trial title. The drug is being developed by Merck & Company, Inc. for contraception.