UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029071 |
|---|---|
| Receipt number | R000033248 |
| Scientific Title | Orlistat as a clomiphene citrate adjuvant in overweight and obese patients with polycystic ovary syndrome. |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2019/09/11 02:13:35 |
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Basic information
Public title
Orlistat as a clomiphene citrate adjuvant in overweight and obese patients with polycystic ovary syndrome.
Acronym
Orlistat as a clomiphene citrate adjuvant in overweight and obese patients with polycystic ovary syndrome
Scientific Title
Orlistat as a clomiphene citrate adjuvant in overweight and obese patients with polycystic ovary syndrome.
Scientific Title:Acronym
Orlistat as a clomiphene citrate adjuvant in overweight and obese patients with polycystic ovary syndrome
Region
| Africa |
Condition
Condition
recruiting
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacy of orlistat in overweight and obese PCO patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
clinical pregnancy rate
Key secondary outcomes
weight reduction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
receive clomiphene citrate for 6 months 5 days at the start of menstruation
plus orlista 3 times/day for 6 months or stopped when patient get pregnant
Interventions/Control_2
receive clomiphene citrate only for 5 days / month for 6 months only
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
PCO patients diagnosed by revised Rotterdam's criteria 2003
age 18-35years
BMI >25 and <35
no recent history of drug intake or deitary modifications
Key exclusion criteria
Male factor
all other causes of infertility
untreated hypothyriodism
hyperprolactinemia
renal or hepatic impairment
malabsorption syndrome
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta University
Division name
Eman Heikal
Zip code
31111
Address
Tanta university
TEL
+201020972067
ayman.dawood@med.tanta.edu.eg
Public contact
Name of contact person
| 1st name | Ayman |
| Middle name | Shehata |
| Last name | Dawood |
Organization
Tanta university
Division name
Eman Heikal
Zip code
31111
Address
Tanta university
TEL
+201020972067
Homepage URL
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta university
Obstetrics and Gynecology department
Institute
Department
Personal name
Funding Source
Organization
Tanta University
Obstetrics and gynecology department
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tanta University
Address
Elgeish st., Tanta, Egypt
Tel
+201020972067
ayman.dawood@med.tanta.edu.eg
Secondary IDs
Secondary IDs
YES
Study ID_1
Eman Heikal
Org. issuing International ID_1
Tanta University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 08 | Day |
Last modified on
| 2019 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033248
