None listed
Conditions
Brief summary
Hirsutism is a distressing and relatively common endocrine problem in women which may prove difficult to manage. Treatment consists of suppressing ovarian or adrenal androgen secretion, or blocking androgen actions in the skin. The major drugs used are gonadotropin-releasing hormone agonists, combined oral contraceptives (COCs), and steroidal (cyproterone acetate(CPA) and spironolactone) or nonsteroidal (flutamide and finasteride) antiandrogens.[1] COCs have been used to treat androgenic symptoms because of their ability to suppress the secretion of gonadotrophins, ovarian or adrenal androgens, and to stimulate the hepatic synthesis of sex hormone-binding globulins (SHBG) resulting in decreased bioactive testosterone. COCs are more effective when associated with antiandrogens. Moreover, oral contraceptives will reduce the risk of irregular bleeding and provide adequate contraception, particularly in the face of the teratogenic potential of antiandrogens, and will potentiate the effectiveness of therapy by suppressing circulating androgen levels. Antiandrogens prevent androgens from expressing their activity at target tissues. Spironolactone is an aldosterone-antagonist diuretic, with antiandrogenic properties. It competitively inhibits the interaction of dihydrotestosterone (DHT) with its intracellular androgen receptors. Additionally, spironolactone inhibits 5a-reductase activity in the target tissues and inhibits the cytochrome P450 system (17-hydroxylase and 17,20-lyase activities) within the ovaries and in the adrenals. The drug can be used alone in doses of 100 to 200 mg daily or in combination with the COCs. CPA is a synthetic progestogen derived from 17a-hydroxyprogesterone. It has antigonadotropic and antiandrogenic peripheral activity. It inhibits the activity of testosterone and DHT by binding to intracellular receptors and decreases ovarian androgen secretion by inhibiting LH release. Furthermore, CPA decreases 5a-reductase activity and increases metabolic clearance of testosterone. It is most conveniently administered as the COC which is effective in controlling acne and hirsutism alone, or in combination with spironolactone 100 mg daily. To the best our knowledge, there is no head to head comparison of efficay of different combinations of COCs and antiandrogens in the treatment of hirsutism in the medical literature. Therefore, our aim was to compare the efficacy and safety of three different combinations of COCs and antiandrogens in the treatment of moderate and severe hirsutism.
Interventions
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 Tr
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.
Sponsors
Dr Sefa Kelekci
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
17 Years to 35 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed