Comparing the effect of Oral Contraceptive LD and Vitex to treat Polycystic ovarian syndrome

Phase 2

• Conditions: polycystic ovarian syndrome.; Sclerocystic ovary syndrome Stein-Leventhal syndrome

• Registration Number: IRCT201306116709N13
• Lead Sponsor: Research deputy of Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

oligomenorrhea or amenorrhea (menstrual intervals longer than 35 days or no menstruation in the last three months); polycystic ovarian confirmed by ultrasound; age 45-18 years; willingness to participate in the study; Body mass index between 18 and 35. Exclusion criteria: having other androgenic disorders such as adrenal hyperplasia or androgen-producing tumors; contraindications of oral contraceptive LD including: smokers over 35 years, active liver diseases, systolic blood pressure equal to or above 140 mm Hg and diastolic equal to or above 90 mm Hg , diabetes for more than 20 years, gallbladder diseases, history of stroke, blood clots in the legs or lungs, heart attack and other cardiovascular problems, breast cancer, migraine with aura,... ; thyroid diseases; cushing's syndrome; currently taking oral contraceptives or other hormonal treatments; pregnancy; breastfeeding; history of surgery on one or both ovaries; taking dopamine antagonist drugs such Thioridazine, Promazine, Metoclopramide, Hydroxyzine, etc

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Menstrual cycle length. Timepoint: One month, two months, three months after the intervention. Method of measurement: Calendar.

Secondary Outcome Measures

Name	Time	Method
Serum Dehydroepiandrosterone sulfate level. Timepoint: Before the intervention and three months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Serum free testosterone level. Timepoint: Before the intervention and three months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).;Serum prolactin levels. Timepoint: Before the intervention and three months after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA).