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IRCT201306116709N13 IRCT 2014-03-02 Research deputy of Tabriz University of Medical Sciences Comparing the effect of Oral Contraceptive LD and Vitex to treat Polycystic ovarian syndrome Comparing the effect of Oral Contraceptive LD and Vitex on improvement clinical and paraclinical parameters of Polycystic ovarian syndrome (PCOS): a double blind randomized controlled clinical trial 2014-01-10 anticipated 80 Complete https://irct.ir/trial/7126 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 polycystic ovarian syndrome. Intervention 1: Intervention group: Vitex agnus tablet, containing standardized pure extract of Vitex agnus fruits with 2.1 to 3.3 mg acubin, two pills daily for three cycles of 28 days . Intervention 2: Control group: LD tablet, containing 30 mcg ethinyl estradiol and 150 mcg levonorgestrel, one pill daily for first 21 days of each cycle through three cycles of 28 days. The last seven tablets in LD group contain placebo.
public Parvaneh Ghahremani nasab
South Shariati street, Faculty of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 5173957675 +98 41 1478 8109 ghahremani.parvaneh@yahoo.com Tabriz University of Medical Sciences scientific Mahnaz Shahnazi
South Shariati street, Faculty of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 51745347 +98 41 1477 2699 mshahnazi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 45 years Female E28.2 Sclerocystic ovary syndrome Stein-Leventhal syndrome Treatment - Drugs Treatment - Drugs Intervention group: Vitex agnus tablet, containing standardized pure extract of Vitex agnus fruits with 2.1 to 3.3 mg acubin, two pills daily for three cycles of 28 days . Control group: LD tablet, containing 30 mcg ethinyl estradiol and 150 mcg levonorgestrel, one pill daily for first 21 days of each cycle through three cycles of 28 days. The last seven tablets in LD group contain placebo. Menstrual cycle length. Timepoint: One month, two months, three months after the intervention. Method of measurement: Calendar. 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). Research deputy of Tabriz University of Medical Sciences Approved 2013-12-09 Ethics committee of Tabriz university of Medical Sciences Golgasht Street, Tabriz Tabriz Iran (Islamic Republic of)