Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT04485403
Eligibility Criteria:
Inclusion Criteria (patient should meet all the criteria)
1. Diagnosis of PCOS according to Rotterdam Criteria
2. Written consent to participate in a clinical trial
3. Age up to 40 years
4. Irregular periods (\> 35 days) or secondary amenorrhea over 3 months
5. Hyperandrogenism (hirsutism and / or acne) and / or total serum testosterone\> 0.5 ng / mL
Exclusion Criteria:
1. A diagnosed chronic disease, including in particular:
* Cancer of the ovary, adrenal gland, endometrium, cervix, mammary gland
* Congenital adrenal hyperplasia (17-OH- progesterone\> 2 ng / mL)
* Clinically diagnosed Cushing's disease, acromegaly, gigantism
* Type I or II diabetes
* Gastrointestinal diseases (peptic ulcer, inflammatory bowel disease, liver disease)
* Active or history of gastric and duodenal ulceration, perforation or bleeding, also following NSAIDs. Gastrointestinal bleeding
* Severe hepatic impairment, severe renal insufficiency or severe heart failure.
* Hemorrhagic diathesis.
* systemic lupus erythematosus and mixed connective tissue disease
* a history of hypertension and cardiac dysfunction
* kidney problems
2. Unexplained vaginal bleeding
3. Use of hormonal treatment currently or during the last 2 months
4. Unexplained abdominal pain
5. Chronic use of drugs, especially: lithium salts, warfarin, oral hypoglycaemics, contraceptives, methotrexate, drugs that lower blood pressure, ACE inhibitors, b-blockers, diuretics that may cause interactions with ibuprofen, corticosteroids, mifepristone,
6. Hypersensitivity to ibuprofen or any of the excipients.
7. Existing or past allergy symptoms in the form of a runny nose, urticaria or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs., Cyclosporin, quinoline antibiotics
8. Pregnancy and lactation
9. Concomitant use of other nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors (increased risk of side effects).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04485403
Study Brief:
Protocol Section:
NCT04485403