Medical abortion in very early pregnancy

Phase 1

• Conditions: nwanted pregnancy; MedDRA version: 21.1Level: PTClassification code 10046267Term: Unwanted pregnancySystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-003675-35-DK
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-09
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

1. Women 18 years of age or above eligible for medical abortion
2. No signs of pathological pregnancy
3. No confirmed IUP
4. Willing and able to participate after the study has been explained
5. Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Allergy towards mifepristone or misoprostol
2. A medical condition or disease that requires special treatment, care
or precaution (e.g. corticosteroid or anticoagulant therapy) in
conjunction with abortion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified