Comparison the therapeutic effect of Clonidine, Yohimbine and Nalterexone on removing the ovarian cyst in poly-cystic ovary syndrome patients referred to Valie-Asre Clinical Center, Imam Khomeini Hospital, Tehran
Women with polycystic ovary syndrome have significantly higher sympathetic nerve activity than their control groups and the increased sympathetic outflow is related to hormonal and metabolic features. Polycystic ovary is characterized by increased luteinizing hormone pulse frequency and amplitude and it is well known that one of the major neurotransmitters that control luteinizing hormone secretion is noradrenaline. The central Beta-endorphin system has a regulatory role in reproduction and autonomic functions. Beta-endorphin is inhibitory modulator of the Gonadotropin releasing hormone pulse generator and pituitary luteinizing hormone release. Thus polycystic ovary syndrome may partly result from insufficient central Beta-endorphin inhibition of Gonadotropin releasing hormone. The aim of evaluation effect of three drugs: Nalterxone, Clonidine and Yohimbine is decreasing overactivity of sympathetic nervous system. Clonidine and yohimbine are used for sympathic agonist and antagonist and Nalterxone is used for opioid system inhibition, because endogenous opioids have modulating role on cathecolamine secretion. Eighty eight women with polycystic ovary syndrome, aging 20-40 years were divided into four groups: three drug groups and one control group. Drugs are: Nalterxone capsule 0.5 mg. daily after dinner, Clonidine tablet 0.2 mg. twice0.1 mg. after breakfast and dinner and Yohimbine tablet 0.5 mg. after dinner for two mounts. The patients had no systemic medical disease, history of medication and their body mass index was less than 28.The main outcomes measurment in this study are serum levels of estradiol, FSH,LH,insuline and also adrenaline,noradrenaline, Beta-endorphine and cortisol.
General information
Acronym
polycystic ovary syndrome PCOS
IRCT registration information
IRCT registration number:IRCT201204027883N4
Registration date:2012-05-23, 1391/03/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-23, 1391/03/03
Registrant information
Name
Farideh Zangeneh
Name of organization / entity
Vali-e-Asr, Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
fzafari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research- Tehran University Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutic effect of Clonidine, Yohimbine and Nalterexone on removing the ovarian cyst in poly-cystic ovary syndrome patients referred to Valie-Asre Clinical Center, Imam Khomeini Hospital, Tehran
Public title
Effect of Clonidine, Yohimbine and Nalterexone on polycystic ovary syndrome patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female, age20-40 and they are suffering of Polycystic ovary syndrome
exclusion criteria:Body Mass Index:28, without basis disease and must not use drug.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chanellor for research of Tehran University Medical Sciences
Street address
Central building of Tehran University of Medical Sciences