ABSTRACT
A prospective, open, single-center, uncontrolled phase IV study examined the efficacy and tolerability of a 6-month oral sequential hormone replacement therapy (estradiol valerate and levonorgestrel; Klimonorm in 50 outpatient peri- and postmenopausal Thai women. The clinical effectiveness of the drug was demonstrated by a rapid alleviation of the classical vasomotor menopausal complaints and a favorable effect on lipid metabolism. A rapid reduction in climacteric complaints ranging up to the complete absence of symptoms was achieved during the first 3 months of treatment. The positive effect on lipid metabolism was demonstrated by a clear reduction in total cholesterol and triglycerides as well as a slight reduction in the LDL fraction and a significant increase in the HDL fraction. The therapy resulted in stabilization of the cycle length. Cycles with regular withdrawal bleeding periods lasting 3 to 4 days with mostly mild intensity were restored in most of the women. The thickness of the endometrium measured sonographically did not change significantly. The drug was safe and well tolerated by most of the women. There were no clinically significant changes in body weight, blood pressure, hematological tests, and other laboratory parameters. Compliance was very good with a dropout rate due to undesirable side effects of only 5%.
Subject(s)
Climacteric/drug effects , Estradiol/analogs & derivatives , Estradiol/pharmacology , Estradiol/therapeutic use , Hormone Replacement Therapy , Levonorgestrel/pharmacology , Levonorgestrel/therapeutic use , Treatment Outcome , Administration, Oral , Aged , Biological Availability , Blood Glucose/chemistry , Blood Glucose/metabolism , Breast/drug effects , Cholesterol/blood , Climacteric/blood , Drug Combinations , Endometrium/drug effects , Estradiol/adverse effects , Fasting , Female , Hemorrhage/drug therapy , Hot Flashes/drug therapy , Hot Flashes/physiopathology , Humans , Levonorgestrel/adverse effects , Lipids/blood , Menstruation/drug effects , Middle Aged , Patient Compliance , Prospective Studies , Thailand/ethnology , Triglycerides/bloodABSTRACT
The efficacy and safety of the low dose monophasic oral contraceptive (OC) combination containing 30 micrograms of ethinylestradiol (EE) and 2.0 mg of dienogest (DNG) (EE/DNG) was evaluated in a prospective, open-label, multicenter, uncontrolled, phase III trial. The trial was carried out in five hospitals in Poland, and included 431 healthy women (aged 18-35 years), over 12 cycles, with a total of 4608 cycles. EE/DNG provided reliable ovulation inhibition. No women became pregnant during the trial. The unadjusted Pearl index was 0. EE/DNG provided good cycle control and reduced the incidence of intermenstrual bleedings, the intensity of menstrual bleeding and frequency of dysmenorrhea. Due to the antiandrogenic properties of the progestogen component DNG, EE/DNG improved androgen-related conditions, such as skin blemishes, hair greasiness and acne vulgaris. Of 50 women with acne, 80% improved after the 6th cycle and 1 was healed. After 12 cycles, 54% were improved and 37% were healed. Breast tenderness and gastric complaints were the most frequent of the common complaints due to treatment with EE/DNG. The frequency of all complaints decreased steadily over time. Only 5.6% of subjects discontinued due to adverse reactions. No thrombophlebitic events were noticed.
Subject(s)
Contraceptives, Oral, Combined/pharmacology , Ethinyl Estradiol/administration & dosage , Nandrolone/analogs & derivatives , Nandrolone/administration & dosage , Acne Vulgaris/chemically induced , Adult , Contraceptives, Oral, Combined/adverse effects , Ethinyl Estradiol/adverse effects , Female , Hair/drug effects , Humans , Nandrolone/adverse effects , Prospective Studies , Skin/drug effectsABSTRACT
The efficacy and safety of the low dose monophasic oral contraceptive (OC) combination containing 30 micrograms of ethinylestradiol (EE) and 2.0 mg of dienogest (DNG) (EE/DNG) was evaluated in a prospective, open-label, multicenter, uncontrolled, phase III trial. The trial was carried out in six hospitals by 36 investigators in the Czech Republic, and included 557 healthy women (aged 18-35 years), over 12 cycles, with a total of 6051 cycles. EE/DNG provided a reliable ovulation inhibition. The contraceptive efficacy study showed an adjusted Pearl index of 0.198 on the basis of three pregnancies occurring during 6051 cycles. EE/DNG provided good cycle control, reduced the incidence of intermenstrual bleedings, the intensity of menstrual bleeding and frequency of dysmenorrhea. Due to the antiandrogenic properties of the progestogen component DNG, EE/DNG improved androgen-related conditions, such as skin blemishes, hair greasiness and acne vulgaris. From 108 women with acne, 62 (57%) improved after the 6th cycle, and 16 (15%) were healed. Similar changes were found after cycle 12. Breast tenderness and headache were the most frequent of the common complaints due to treatment with EE/DNG. The frequency of all complaints decreased steadily over time. Only 7.7% of subjects discontinued due to adverse reactions. No thrombophlebitic events were noticed.
