The Effect of Ibuprofen on Women With PCOS.

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Polycystic ovary syndrome occurs in about 10% of women of childbearing age. His pathogenesis is not fully understood. More and more research concerns the role of chronic inflammation in these women as the cause of the disease. In vitro studies have shown a significant reduction in testosterone production by teak cells after ibuprofen. The goal of the project is to use a low dose of ibuprofen in women with PCOS to lower androgen levels.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poznan University of Medical Sciences
• Treatments: Ibuprofen

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).