Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000604202
Ethics application status
Approved
Date submitted
16/07/2009
Date registered
21/07/2009
Date last updated
21/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Combined oral contraceptives plus spironolactone or cyproterone acetate for hirsutism: Randomized comparison of three regimens
Scientific title
Randomized prospective study to compare the efficacy and safety of combined oral contraceptives plus spironolactone or cyproterone acetate for the treatment of hirsutism
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The treatment of moderate and severe hirsutism 237264 0
Condition category
Condition code
Metabolic and Endocrine 239586 239586 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
According to a computer generated randomization table, women were randomly assigned to three treatment groups: Thirty mcg ethinyl estradiol plus 3 mg drospirenone (Yasmin 'Registered Trademark', Schering AG, Berlin, Germany)/cyproterone acetate 50 mg (Androcur 'Registered Trademark', Schering AG, Berlin, Germany) was given in Group I (n=45), 30 mcg ethinyl estradiol plus 3 mg drospirenone (Yasmin 'Registered Trademark',Schering AG, Berlin, Germany)/Spironolactone 100 mg (Aldactone 'Registered Trademark', Aris, Istanbul, Turkey) was given in Group II (n=44) and 35 mcg ethinyl estradiol plus 2 mg cyproterone acetate 35 (Diane 'Registered Trademark', Schering AG, Berlin, Germany)/cyproterone acetate 50 mg (Group III; n=45). Randomization was carried out blindly with respect to the patient’s clinical features while patients were not blind to treatment regimens. Patients were told to take combined oral contraceptives (pills containing both estrogens and progesterones) for 21 days as oral blisters, followed by a 7-day pill-free period. In group I and III, cyproterone acetate (2x50 mg/day) was recommended to be taken for the first 14 days of the cycle while Spironolactone was advised with the regimen of 100 mg/day during treatment period (everyday for 6 months) once per day only as oral capsules. Therapy was were started on the 1st day of the menstrual cycle and continued for 6 months.
Intervention code [1] 236947 0
Treatment: Drugs
Comparator / control treatment
Treatment groups are consisted of 3 groups and all of them were active as described above
Control group
Active

Outcomes
Primary outcome [1] 238380 0
The decrease in hirsutism score, which was always evaluated by the same physician by the modified Ferriman-Gallwey score, who was blinded to treatment groups.
Timepoint [1] 238380 0
At 3 rd and 6 th months after the start of treatment.
Secondary outcome [1] 244830 0
Changes in ovarian morphology (Policystic ovary or not by ultrasonography)
Timepoint [1] 244830 0
At 3 rd and 6 th months after the start of treatment. It was always evaluated by the same physician using ultrasonography, who was blinded to treatment groups.
Secondary outcome [2] 244831 0
Changes in serum androgen profiles regarding total testosterone, dehydroepiandrosterone sulphate and 17-hydroxyprogesterone
Timepoint [2] 244831 0
They were obtained at the early follicular phase of patents' spontaneous menstruation before, and on three and six months after treatment using radioimmunoassay commercial kits.

Eligibility
Key inclusion criteria
Nulligravid women with moderate-to-severe hirsutism, non-pregnant women or women who do not wish to become pregnant, no smoking, no history of breast cancer and endometrium cancer, no active liver disease, no history of thromboembolic disease, no treatment for hirsutism before.
Minimum age
17 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with thyroid disease, diabetes mellitus, adrenal disorders,
hyperprolactinemia, or any other disorder were excluded from the study. Women with hirsutism due to androgen excess such as late-onset congenital adrenal hyperplasia were not included in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation was predetermined and placed in consecutively numbered opaque, sealed envelopes. The next consecutive envelope was drawn after the patient consented to randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was performed with use of a computer generated random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1884 0
Turkey
State/province [1] 1884 0

Funding & Sponsors
Funding source category [1] 237338 0
Self funded/Unfunded
Name [1] 237338 0
Dr Kiymet Handan Kelekci
Country [1] 237338 0
Turkey
Primary sponsor type
Individual
Name
Dr Sefa Kelekci
Address
Belediye evleri mah
Vilko sitesi No: 45
84220, Cukurova, Adana
Country
Turkey
Secondary sponsor category [1] 236825 0
Individual
Name [1] 236825 0
Dr Bulent Yilmaz
Address [1] 236825 0
Camlitepe mah, Taskent Sokak, 26/8, 06600, Kurtulus, Ankara
Country [1] 236825 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239456 0
Human Research and Ethics Committee of the Numune Education and Research Hospital, Adana, Turkey
Ethics committee address [1] 239456 0
Ethics committee country [1] 239456 0
Date submitted for ethics approval [1] 239456 0
Approval date [1] 239456 0
Ethics approval number [1] 239456 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29905 0
Address 29905 0
Country 29905 0
Phone 29905 0
Fax 29905 0
Email 29905 0
Contact person for public queries
Name 13152 0
Bulent Yilmaz, MD
Address 13152 0
Camlitepe mah, Taskent Sokak, 26/8, 06600, Kurtulus, Ankara
Country 13152 0
Turkey
Phone 13152 0
+9005053574351
Fax 13152 0
Email 13152 0
[email protected]
Contact person for scientific queries
Name 4080 0
Bulent Yilmaz, MD
Address 4080 0
Camlitepe mah, Taskent Sokak, 26/8, 06600, Kurtulus, Ankara
Country 4080 0
Turkey
Phone 4080 0
+9005053574351
Fax 4080 0
Email 4080 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.