Evaluating the use of ulipristal acetate with and without misoprostol for contragestion

ISRCTN	ISRCTN78613350
DOI	https://doi.org/10.1186/ISRCTN78613350
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	1001
Sponsor	Verge Research
Funders	David and Lucile Packard Foundation, Secretaría de Salud de la Ciudad de México (SEDESA), Verge Research

Submission date: 28/09/2025
Registration date: 15/10/2025
Last edited: 15/10/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This proof-of-concept study will assess the safety, efficacy, and acceptability of use of ulipristal acetate (UPA) with and without misoprostol for prevention and/or disruption of early pregnancy processes through 35 days since the last menstrual period (LMP). Although UPA is known to be effective when used before ovulation for pregnancy prevention, and recent evidence suggests it is highly effective when used with misoprostol for termination of confirmed pregnancies up to 63 days LMP, its potential for pregnancy prevention and/or disruption in the initial post-ovulatory period through 35 days LMP has not been studied in humans. If either regimen is shown is found to be safe, effective and acceptable when used as a contragestive through 35 days LMP, this would fill an important gap in available fertility control methods.

Who can participate?
Women at risk of unwanted pregnancy who are between the ages of 18 and 39 years, over 5 days since unprotected intercourse and 35 days or less since the last menstrual period (LMP)

What does the study involve?
Participants will provide a blood sample at the time of enrollment and will then be randomly assigned to receive either 60 mg of ulipristal acetate followed by 800 mcg misoprostol 24 hours later, or 60 mg of ulipristal acetate followed by placebo pills 24 hours later. Follow-up takes place at the study clinic approximately 14 days after taking the ulipristal acetate and includes a pregnancy test and exit interview and, for those with a positive test result, an ultrasound. The main outcomes assessed are pregnancy status at follow-up, safety and patient satisfaction.

What are the possible benefits and risks of participating?
Participants may benefit from access to a safe and effective option for pregnancy prevention and/or disruption under close medical supervision. Risks include expected side effects of the medications, including cramps, bleeding, nausea, vomiting, chills and fever. Serious side effects are rare but monitored closely, and clinical care is provided if needed.

Where is the study run from?
The study is carried out in one maternity hospital in Mexico City (Hospital Materno Infantil Inguarán) and three private clinics in Mexico City (Cuidado Integral de la Mujer, Gineclinic, S.C., Integra, MDK, and Centro Médico Mujer).

What is the study starting date and how long is it expected to run for?
October 2024 to December 2026

Who is funding the study?
The study is jointly funded by Verge Research (New York, USA) and the Secretaría de Salud de la Ciudad de México (SEDESA)

Who is the main contact?
Manuel Bousiéguez, (Senior Associate, Verge Research), mbousieguez@vergeresearch.org

Contact information

Dr Wendy Sheldon
Public, Scientific, Principal investigator

41 Purdy Avenue #663
Rye
10580
United States of America

Phone	+1 (0)9172879052
Email	wsheldon@vergeresearch.org

Dr Angélica Martínez Huitrón
Principal investigator

Parque Bosencheve numero 2, interior 8, Colonia El Parque
Naulcalpan
53398
Mexico

Phone	+52 (0)55 2300 1401
Email	martinezangelica995@gmail.com

Mr Manuel Bousiéguez
Principal investigator

Agricultura # 45 PH 4. Col. Escandon
Mexico City
11800
Mexico

Phone	+52 (0)55 5418-6607
Email	mbousieguez@vergeresearch.org

Study information

Primary study design	Interventional
Study design	Multicenter interventional doubled-blinded randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Safety, efficacy and acceptability of ulipristal acetate with and without misoprostol for contragestion through 35 days LMP
Study objectives	To evaluate the safety, efficacy, and acceptability of using 60 mg of ulipristal acetate, alone or in combination with 800 mcg of misoprostol, for preventing and/or terminating unwanted pregnancy up to 35 days since a woman's last menstrual period (LMP).
Ethics approval(s)	1. Approved 05/05/2025, Allendale Investigational Review Board (30 Neck Road, Old Lyme, CT, 06371, United States of America; +1 (0)860 575 0092; erin.staab@allendaleirb.com), ref: Protocol #1001 2. Submitted 19/08/2025, Research Ethics Committee, Belisario Domínguez Specialty Hospital (Av. Tláhuac No. 4866, esq. Zacatlán. Col. San Lorenzo Texcoco. Alcaldía Iztapalapa, Mexico City, 09790, Mexico; +1 (0)52 55 5850 0000 Ext. 1064; dgpcs.correspondencia@salud.cdmx.gob.mx), ref: N/A (number will be provided after approval)
Health condition(s) or problem(s) studied	Prevention or disruption of unwanted pregnancy in women up to 35 days LMP
Intervention	Arm 1: 60 mg (two 30 mg tablets) ulipristal acetate orally, followed 24 hours later by 800 mcg (four 200 mcg tablets) of misoprostol buccally. Arm 2: 60 mg (two 30 mg tablets) ulipristal acetate orally, followed 24 hours later by four placebo tablets buccally. Randomization is 1:1 and carried out in blocks of 8 for each study site using a computer program.
Intervention type	Drug
Phase	Phase I/II
Drug / device / biological / vaccine name(s)	Ulipristal acetate, misoprostol
Primary outcome measure(s)	Proportion of study participants not pregnant at follow-up, as determined by urine pregnancy test and, for those with a positive urine test, ultrasound
Key secondary outcome measure(s)	1. Self-reported incidence of side effects (diarrhea, nausea/vomiting, cramps, fever, chills or other) after taking the study medications, as measured by an exit interview at follow-up. 2. Acceptability of the contragestive medications to participants, defined as the proportion of participants who report at follow-up that the medications were acceptable or highly acceptable. 3. Incidence of bleeding within five days after administering the study medications, defined as the proportion of participants who report at follow-up that they experienced any bleeding in the first 5 days after taking the study medications. 4. Duration of bleeding in days following administration of the study medications, defined as the number of days that participants report experiencing bleeding after taking the study medications, as measured by an exit interview at follow-up. 5. Severity of bleeding following administration of study medications, defined as the proportion of participants who report that the bleeding they experienced was very severe, somewhat severe, or not severe at all, as measured by an exit interview at follow-up.
Completion date	31/12/2026

Eligibility

Participant type(s)	Healthy volunteer
Age group	Other
Lower age limit	18 Years
Upper age limit	39 Years
Sex	Female
Target sample size at registration	500
Key inclusion criteria	1. Age 18-39 years 2. LMP ≤35 days, as verified by report of last menstrual period 3. Missed the EC window (had unprotected sex >5 days ago) 4. General good health 5. Does not want to be pregnant 6. History of regular monthly menstrual cycles (±3 days) 7. Willing and able to understand and sign consent forms 8. Willing to return for a follow-up visit 9. Willing to provide a blood draw at enrollment and urine sample at follow-up
Key exclusion criteria	1. Known allergies or contraindications to either of the study drugs 2. Symptoms of or risk factors for ectopic pregnancy, including: 2.1. Unilateral pelvic pain or significant bilateral pelvic pain within the past week 2.2. Prior ectopic pregnancy 2.3. Prior permanent contraception or other tubal surgery 3. Current use of an IUD, contraceptive implant or injectable 4. History of renal or liver disease
Date of first enrolment	01/11/2025
Date of final enrolment	31/12/2026

Locations

Countries of recruitment

Mexico

Study participating centres

Hospital Materno Infantil Inguarán

Estaño # 307
Col. Felipe Ángeles
Alc. Venustiano Carranza
Mexico City
15310
Mexico

Cuidado Integral de la Mujer, Gineclinic, S.C.

Barranca del Muerto 516
Los Alpes
Álvaro Obregón
Mexico City
01010
Mexico

Centro Médico Mujer

Av. Baja California 111B
Roma Sur
Cuauhtémoc
Mexico City
06760
Mexico

IntegraMDK

Temístocles 219
Polanco Iv Sección
Miguel Hidalgo
Mexico City
11560
Mexico

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/09/2025: Study's existence confirmed by the Allendale Investigational Review Board.