The Effect of Ibuprofen on Women With PCOS.

NCT04485403 | Unknown Phase 2

• 1 other identifier: 761/19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

PCOS; Hyperandrogenism; Inflammation

Keywords

PCOS; IBUPROFEN; TESTOSTERON; HYPERANDROGENISM

Outcome Measures

Primary Outcomes (1)

• Decrease of Testosteron levels

  total testosterone level measurement

  3 weeks

Secondary Outcomes (1)

• Decrease in hyperandrogenism markers

  3 weeks

Other Outcomes (1)

• Influence of ibuprofen on the decrease chronic inflammatory state in PCOS patients

  3 weeks

Study Arms (1)

Ibuprofen

EXPERIMENTAL

Depending on body weight, patients will be divided into two groups. Women with a body weight \<70 kg will be taking a daily dose of 800 mg ibuprofen orally. Women ≥ 70 kg will take a dose of 1200 mg ibuprofen orally. Before and after 3 weeks of treatment, all subjects will have a full hormonal, biochemical and clinical profile.

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

800 mg/day ( 2 x 400mg) for 3 weeks in women with a bodyweight \<70 kg, and a dose of 1200 mg/day (3x400mg) in women weighing\> 70kg. The effects of treatment will be compared on the basis of changes in the hormonal profile and inflammatory markers, as well as the clinical assessment of the patient.

Ibuprofen

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics

Poznan, Greater Poland Voivodeship, 60-535, Poland

Location

MeSH Terms

Conditions

Hyperandrogenism; Inflammation

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Beata Banaszewska

  Poznan University of Medical Sciences, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Associate Proffesor Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: September 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)