EUCTR2007-003788-28-BE进行中（未招募）1 期
A double-blind, placebo controlled, randomized, comparative, mono-centre trial to assess the effects on the androgen metabolism and its effects on biochemical parameters, mood, fat, muscle and bone of continuous supplementation with dehydroepiandrosterone in women using a monophasic contraception containing drospirenone and ethinylestradiol - AMUSA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Women aged 18-35 years (inclusive) who are in need for contraception and willing to use an OC for 9 subsequent cycles and who have not been using hormonal contraceptive treatment for at least 3 months prior to randomization;
- •2. Willing to have a documented spontaneous cycle for baseline observation without the use of any hormonal contraceptive treatment and willing to use a non-hormonal contraception instead prior to start study medication;
- •3. Sexually active women;
- •4. Good physical and mental health as judged by the investigator determined by medical history, physical examination, clinical laboratory and vitals signs;
- •5. Regular menstrual cycle (24-35 days) prior to screening;
- •6. At least 18 but not older than 35 years of age at the time of screening;
- •7. Body mass index between (=) 18 and (=) 35 kg/m2;
- •8. Willing to give informed consent in writing.
- •Continued eligibility inclusion criteria for enrolment in the treatment extension:
- •1. Women completing the 9 treatment cycles of the main study who are still fulfilling the study criteria and who are willing to use an OC for another 7 subsequent cycles;
- •2. Good physical and mental health as judged by the investigator determined by physical examination, clinical laboratory and vital signs;
- •3. Willing to give informed consent in writing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Failure to ovulate during the documented spontaneous cycle for baseline observation defined as absence of ovulation documented by a plasma progesterone level of = 1.5 ng/ml measured during the expected luteal phase on a cycle day calculated based on (i) the duration of the spontanuous menstrual cycle in the past, (ii) the duration of the first and the second cycle in case a subject is undergoing a three-month washout period for a contraceptive method. (note: in case of anovulatory cycle, a second baseline observational cycle may be monitored, but in case of two consecutive ovulation failures, the subject will be excluded);
- •2. Use of any hormonal contraceptive method during the documented spontaneous cycle prior to start of study medication;
- •3. Previous use of any hormonal contraceptive method during the last 3 months prior to screeningrandomization;
- •4. Use of any long term hormonal method (e.g. Depo-provera®) of contraception within 3 months after the limit of efficacy determined according to the manufacturer and no spontaneous return of menstruation prior to screening;
- •5. Androgen therapy during the 6 months prior to screening;
- •6. Polycystic Ovarian Syndrome documented by either previous clinical abnormal cyclicity and/or FSH/LH ratio or echographic documentation of multiple cystic ovarian syndrome;
- •7. Hyperandrogenism documented by free serum testosterone value (? 9 pg/mL), severe acne and/or hirsutism;
- •8. No spontaneous menstruation has occurred following a delivery or abortion;
- •9. Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation;
- •10. Intention to become pregnant during the study;
- •11. An abnormal cervical smear
- •12. Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening;
- •13. History of/or current (treated) skin disorder;
- •14. Any clinically significant abnormality following review of medical history, laboratory results and physical/gynaecological examination at screening as judged by the investigator;
- •15. Contraindications for contraceptive steroids:
- •Continued eligibility exclusion criteria for enrolment in the treatment extension:
- •1. Use of any hormonal contraceptive method (except the study medication) during and/or directly after the blinded treatment period of the main study;
- •2. Androgen therapy during and directly after the blinded treatment period of the main study;
- •3. Any medical event occurring or condition arising during the study period of the main study that, in the opinion of the investigator, could interfere with optimal participation in the study or jeopardize the subjects health if left untreated;
- •4. Any clinically significant abnormality following review of laboratory results at Visit 6 as judged by the Investigator;
- •5. Subjects with a positive result for pregnancy test at Visit 6;
- •6. Non-compliance with the study medication during the main study to such extent that the evaluation of study data is compromised.
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