Polycystic ovary syndrome (PCOS)
Conditions
Interventions
Treatment group:Study Medication: Desogestrel and Ethinyl Estradiol Tablets (Gedeon Richter Plc.)
Specifications: Desogestrel 0.15 mg, Ethinyl Estradiol 20 µg per tablet
Recommended Usage: Start takin
Sponsors
Sichuan Provincial Maternal and Child Health Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1)Meeting the 2003 ESHRE/ASRM (Rotterdam) diagnostic criteria for PCOS (2) Female aged between 18 and 40 years old (3) Voluntarily participating in the study and having signed the informed consent form
Exclusion criteria
Exclusion criteria: (1)Patients with venous/arterial thrombotic diseases or at risk of such conditions. (2)Patients with pancreatitis associated with severe hypertriglyceridemia or those with a history of such. (3)Patients with hepatic or renal insufficiency. (4)Patients with hepatic tumors (benign or malignant) or a history of such. (5)Patients with known or suspected malignancies that are hormone-dependent (such as malignant tumors of the reproductive organs or breast). (6)Endometrial hyperplasia. (7)Unexplained vaginal bleeding. (8)Patients allergic or intolerant to the active ingredients of the treatment or any excipients. (9)Patients who have used other combined oral contraceptives (such as ethinyl estradiol and cyproterone acetate tablets, or drospirenone and ethinyl estradiol tablets) or medications that affect hormone levels within the past month. (10)Patients who are known or suspected to be pregnant. (11)Patients with the following conditions: systemic lupus erythematosus (as diagnosed by a physician), migraine, women over 35 years of age who smoke, porphyria, otosclerosis-related hearing loss, major surgery requiring prolonged immobilization, diabetes with vascular involvement, severe hypertension. (12)Patients using medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir. (13)Patients with severe mental disorders such as schizophrenia or bipolar affective disorder. (14)Other situations deemed by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion (%) of patients who established a normal menstrual cycle frequency within 3 cycles after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion (%) of patients who established a normal menstrual cycle frequency within 6 cycles after treatment;Change in menstrual period length (normal/prolonged) from baseline to 3 cycles after treatment;Change in menstrual bleeding volume (menorrhagia/hypomenorrhea) from baseline to 3 cycles after treatment;Change in TT relative to baseline from baseline to 3 cycles after treatment;Change in FSH relative to baseline from baseline to 3 cycles after treatment;Change in LH relative to baseline from baseline to 3 cycles after treatment;Change in LH/FSH relative to baseline from baseline to 3 cycles after treatment;Change in sex hormone-binding globulin relative to baseline from baseline to 3 cycles after treatment;Change in dehydroepiandrosterone sulfate relative to baseline from baseline to 3 cycles after treatment;Change in free androgen levels relative to baseline from baseline to 3 cycles after treatment;Change in glucose tolerance (fasting plasma glucose, 2-hour postprandial plasma glucose) relative to baseline from baseline to 3 cycles after treatment;Change in HbA1c levels relative to baseline from baseline to 3 cycles after treatment;Change in fasting plasma insulin levels relative to baseline from baseline to 3 cycles after treatment;Change in Homeostatic Model Assessment of Insulin Resistance relative to baseline from baseline to 3 cycles after treatment;Change in TC levels relative to baseline from baseline to 3 cycles after treatment;Change in TG levels relative to baseline from baseline to 3 cycles after treatment;Change in LDL-C levels relative to baseline from baseline to 3 cycles after treatment;Change in HDL-C levels relative to baseline from baseline to 3 cycles after treatment;Change in body weight relative to baseline from baseline to 3 cycles after treatment;Change in BMI relative to baseline from baseline to 3 cycles after treatment;Change in waist circumference relative to baseline from baseline to 3 cycles after treatment;Change in hip circumfe | — |
Countries
China
Contacts
Public ContactGang Wang
Sichuan Provincial Maternal and Child Health Hospital
Outcome results
None listed