NCT05216952

Ulipristal Acetate for Use in Early Pregnancy Loss

Ulipristal Acetate for Use in Early Pregnancy Loss: A Phase 2 Pilot Feasibility Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators will study the feasibility of using 90mg ulipristal acetate, a selective progesterone receptor agonist, as an adjunct to 800mcg vaginal misoprostol for the medical management of early pregnancy loss. Patients will be followed to assess effective treatment of early pregnancy loss, additional interventions needed, side effects, adverse events and patient acceptability.

Detailed description

Study Background: Early pregnancy loss affects approximately 10% of women throughout their reproductive lives and many women desire medical management of early pregnancy loss. Data from two large randomized controlled trials suggests that pretreatment with mifepristone 200mg, a selective progesterone receptor modulator, prior to administration of misoprostol 800mcg increases effectiveness of medical management of early pregnancy loss and decreases the need for subsequent surgical management. Ulipristal acetate (UPA) is another selective progesterone receptor modulator that may allow for similar priming of the cervix and sensitization of the myometrium to the prostaglandins to improve effectiveness of misoprostol in medical management of early pregnancy loss. Ulipristal acetate is available as a prescription medication through commercial pharmacies. Thus, utilizing UPA plus misoprostol for early pregnancy loss may improve access to patients. Study Objectives: Primary Objective: \- To assess if 90mg ulipristal acetate as an adjunct to 800mcg vaginal misoprostol is a feasible method for medical management of early pregnancy loss. Secondary Objectives: * To evaluate if participants taking ulipristal acetate plus misoprostol achieve complete resolution of early pregnancy loss. * To investigate if patients using ulipristal acetate plus misoprostol have side effects or adverse events when used for early pregnancy loss. * To identify if patients find ulipristal acetate and misoprostol an acceptable treatment for early pregnancy loss. Study Population: Participants eligible for the study include women over age 18 presenting with a non-viable pregnancy between 5- and 12-weeks gestation or an anembryonic gestation and desiring medical management. Study Location: All study activities will take place at University of North Carolina-Chapel Hill (UNC). Participants will be recruited from OBGYN clinics following diagnosis of early pregnancy loss on viability scan. All follow up study activities will take place at UNC Chapel Hill Family Planning Clinic. Study Intervention: Ulipristal acetate is a selective progesterone receptor modulator that is currently FDA approved for the use of emergency contraception. Three 30mg tablets will be administered orally for a total dose of 90mg. Participants will be instructed to self-administer 800mcg of misoprostol 6 to 18 hours after receiving ulipristal acetate as per the standard of care for early pregnancy loss management. Participants will be followed for resolution of their early pregnancy loss.

Conditions

• Missed Abortion
• Anembryonic Pregnancy
• Non-Viable Pregnancy

Interventions

Type	Name	Description
DRUG	Ulipristal Acetate Tablets	90mg (three 30mg tablets) administered orally once
DRUG	Misoprostol Pill	800mcg (four 200mcg pills) administered vaginally once 6-18 hours following ulipristal acetate

Timeline

• Start date: 2022-05-11
• Primary completion: 2023-01-03
• Completion: 2023-04-30
• First posted: 2022-02-01
• Last updated: 2023-06-28
• Results posted: 2023-06-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study