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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201306116709N13
Enrollment
80
Registered
2014-03-02
Start date
2014-01-10
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovarian syndrome. Sclerocystic ovary syndrome Stein-Leventhal syndrome

Interventions

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 . Interventi
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 g

Sponsors

Research deputy of Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

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

Secondary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvaneh Ghahremani nasab

Tabriz University of Medical Sciences

ghahremani.parvaneh@yahoo.com+98 41 1478 8109

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026