Blocking Mifepristone Action With Progesterone

NCT03774745 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 1353650
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone.

Conditions

Pregnancy, Unwanted

Keywords

mifepristone; progesterone; abortion

Outcome Measures

Primary Outcomes (1)

• Continuing Pregnancy Based on Ultrasound Examination

  Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination

  at 14-16 days after mifepristone administration

Secondary Outcomes (4)

• Expulsion During Follow-up Evaluation

  up to 16 days after mifepristone administration

• Number of Participants With Adverse Events During Follow-up Evaluation

  up to 16 days after mifepristone administration

• Medical Safety During Treatment and Follow-up

  up to 16 days after mifepristone administration

• Number of Participants With Change in Serum Progesterone and hCG During Follow-up

  up to 16 days after mifepristone administration

Study Arms (2)

Progesterone

EXPERIMENTAL

Micronized progesterone 200mg oral capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Progesterone treatment days 2-4: two capsules twice daily orally. Progesterone treatment days 5-15, 16 or 17: two capsules once daily orally.

Drug: Mifepristone 200 MG; Drug: micronized Progesterone

Placebo oral capsule

PLACEBO COMPARATOR

Placebo capsules starting 24 hours after mifepristone 200mg ingestion (day 1). Placebo treatment days 2-4: two capsules twice daily orally. Placebo treatment days 5-15, 16 or 17: two capsules once daily orally.

Drug: Mifepristone 200 MG; Drug: Placebo oral capsule

Interventions

Mifepristone 200 MG DRUG

All subjects receive mifepristone tablet on treatment day 1.

Also known as: Mifeprex

Placebo oral capsule; Progesterone

micronized Progesterone DRUG

Subjects randomized to progesterone receive treatment starting day 2.

Also known as: Prometrium

Progesterone

Placebo oral capsule DRUG

Subjects randomized to placebo receive treatment starting day 2.

Also known as: Placebo (for micronized progesterone)

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biologic females who are pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant females 18 years and older at enrollment.
• Seeking surgical abortion at 44-63 days' gestation on Study day 1.
• Have received counseling and signed informed consent per UCD standard procedures for surgical abortion.
• Presence of embryonic gestational cardiac activity on transvaginal ultrasonography.
• English-speaking
• Willing to sign informed consent and follow study protocol.
• Willing to experience potential expulsion of the pregnancy with mifepristone treatment.

You may not qualify if:

• Medical contraindications to medical abortion.
• Poorly controlled hypertension (systolic BP \>160 or diastolic BP \>95)
• Significant anemia - known recent hemoglobin \<9.5 gm/dL
• Clinically significant cardiovascular disease (angina, valvular disease, arrhythmia, or congestive heart failure)
• Breastfeeding
• Coagulopathy or therapeutic coagulation
• Ultrasound evidence of molar or ectopic pregnancy
• Chronic systemic corticosteroid use
• Adrenal disease
• Sickle cell anemia with frequent/recent crises
• Glaucoma
• IUD in place during conception, even if removed.
• Peanut allergy.
• Known intolerance of mifepristone or progesterone.
• Any other condition, that in the opinion of the clinician, would contraindicate mifepristone, progesterone or medical abortion.

Sponsors & Collaborators

• University of California, Davis: lead
• Society of Family Planning: collaborator

Study Sites (3)

Planned Parenthood Mar Monte

Sacramento, California, 95816, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

Family Planning Associates

Sacramento, California, 95825, United States

Location

Related Publications (1)

• Creinin MD, Hou MY, Dalton L, Steward R, Chen MJ. Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jan;135(1):158-165. doi: 10.1097/AOG.0000000000003620.

  PMID: 31809439 DERIVED

MeSH Terms

Interventions

Mifepristone; Progesterone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Limitations and Caveats

Early termination for safety reasons leading to small numbers of subjects analyzed for efficacy outcomes. Imbalance in participant characteristics due to early termination.

Results Point of Contact

• Title: Dr. Mitchell Creinin
• Organization: University of California, Davis

mdcreinin@ucdavis.edu

916-734-6670

Study Officials

• Mitchell D Creinin, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo pills in opaque bottle
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, placebo controlled trial

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: February 11, 2019
• Primary Completion: July 29, 2019
• Study Completion: August 15, 2019
• Last Updated: January 22, 2020
• Results First Posted: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)