Status:
UNKNOWN
The Effect of Ibuprofen on Women With PCOS.
Lead Sponsor:
Poznan University of Medical Sciences
Conditions:
PCOS
Hyperandrogenism
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief 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...
Detailed Description
Polycystic ovary syndrome 1 is diagnosed in about 4-8% of women of childbearing age and is,therefore one of the most common endocrinopathies. The exact pathogenetic mechanism of PCOS is not fully disc...
Eligibility Criteria
Inclusion
- Inclusion Criteria (patient should meet all the criteria)
- Diagnosis of PCOS according to Rotterdam Criteria
- Written consent to participate in a clinical trial
- Age up to 40 years
- Irregular periods (\> 35 days) or secondary amenorrhea over 3 months
- Hyperandrogenism (hirsutism and / or acne) and / or total serum testosterone\> 0.5 ng / mL
- Exclusion Criteria:
- 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
- Unexplained vaginal bleeding
- Use of hormonal treatment currently or during the last 2 months
- Unexplained abdominal pain
- 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,
- Hypersensitivity to ibuprofen or any of the excipients.
- 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
- Pregnancy and lactation
- Concomitant use of other nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors (increased risk of side effects).
Exclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04485403
Start Date
September 1 2019
End Date
December 1 2021
Last Update
July 24 2020
Active Locations (1)
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1
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Poznan, Greater Poland Voivodeship, Poland, 60-535