ISRCTN06414473已完成2 期
A double-blind, placebo controlled, randomised, comparative, single-centre trial to assess the effects on the androgen metabolism and its effect on biochemical parameters, mood, fat, muscle and bone of continuous supplementation with an androgen in women using a monophasic contraception
Pantarhei Bioscience BV (Netherlands)0 个研究点目标入组 100 人开始时间: 2009年12月21日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Healthy females between 18 and 35 years of age who are in need for OC
- •2. No use of hormonal contraceptive treatment for at least 3 months prior to randomisation
- •3. Willing to use an OC for 9 subsequent cycles
- •4. Willing to have a documented spontaneous cycle for baseline observation without the use of any hormonal contraceptive treatment
- •5. Sexually active women
- •6. Regular menstrual cycle (24 - 35 days) prior to screening
- •7. Body mass index (BMI) between (greater than or equal to) 18 and (less than or equal to) 35 kg/m^2
- •8. Good physical and mental health
- •9. Sign a written informed consent agreement
排除标准
- •1. Contraindications for OC
- •2. Failure to ovulate during the documented spontaneous cycle for baseline observation
- •3. Use of hormonal contraceptive method during documented spontaneous cycle
- •4. Previous use of any hormonal contraceptive method during the last 3 months prior to randomisation
- •5. Use of any long term hormonal contraceptive method within 3 months after the limit of efficacy prior to screening
- •6. Androgen therapy during the 6 months prior to screening
- •7. Polycystic ovarian syndrome
- •8. Hyperandrogenism documented by free serum T value (greater than or equal to 9 pg/mL), severe acne and/or hirsutism at screening
- •9. No spontaneous menstruation has occurred following a delivery or abortion
- •10. Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation
- •11. Intention to become pregnant during the study
- •12. An abnormal cervical smear at screening
- •13. Any clinically significant abnormality following review of medical history, laboratory results and physical/gynaecological examination at screening
- •14. Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening
- •15. History of/or current (treated) skin disorder (e.g. acne) which might be influenced by the study treatment
- •16. Use of any relevant treatment for a skin disorder at the time of screening
- •17. Use of one or more of the following medications: psychoactive drugs, anti-hypertensive drugs
- •18. Present use or use within 30 days prior to the start of the study medication of the following drugs: phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post-treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John?s Wort)
- •19. Administration of any other investigational drug within 3 months prior to screening
研究者
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