EUCTR2020-000716-30-CZ进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multicenter, proof-of-concept study to evaluate a combined oral contraceptive (COC) containing 30 µg ethinylestradiol and 150 µg levonorgestrel plus 50 mg dehydroepiandrosterone (DHEA) or placebo to counteract distressing decreased sexual desire secondary to COC use.
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
- 512
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
- •Treatment Period 1
- •1. Women aged 18 to 45 who want to start a COC for contraception and who are willing to use a COC for 6 subsequent cycles.
- •2. Women reporting a satisfying sexual life and who are in a monogamous, sexually active relationship for at least 6 months.
- •3. Women with normal sexual function at screening and at enrollment visit, defined as
- •a. FSFI-6 >19 and
- •b. FSFI-6 Desire item = 3 [i.e., score on 6-item Female Sexual Function Index (FSFI-6) >19 with Desire (1st Item, level of sexual interest) = 3 or higher (1 or 2 = very low or none at all, or low; maximum score = 5)]
- •4. Good physical and mental health as judged by the investigator through prospective evaluation at screening (medical history, physical and gynecological (including breast) examination, clinical laboratory and vital signs).
- •5. Premenopausal women having regular menstrual cycles (21 to 35 days)
- •6. Monogamous partner who is without sexual dysfunction (per female subject's report) and who is available to the subject at least half the time every month.
- •7. Willing to give written informed consent
- •8. Women having a functional relationship as per investigator judgement (considering all information, e.g. interview with the clinician, Locke-Wallace Marital Adjustment Test [MAT] and Decreased Sexual Desire Screener [DSDS]).
- •9. Negative serum pregnancy test at screening and negative urine pregnancy test at enrollment visit.
- •10. Agree to not donate any blood or blood products during the study and in the 3 months after this study.
- •Treatment Period 2
- •1. Decreased sexual function (desire) due to COC use defined as:
- •a) Merits diagnosis of COC-associated HSDD on Decreased Sexual Desire Screener (DSDS-OC) and
- •b) FSFI-6 Desire item < 3
- •2. Good physical and mental health as judged by the investigator through prospective evaluation (physical and gynecological (including breast) examination, clinical laboratory and vital signs)
- •3. Same monogamous partner as during treatment period 1 who is without sexual dysfunction (per female subject's report) and who is available to the subject at least half the time every month
- •4. Women continue to have a functional relationship as per subject report
- •5. Negative urine pregnancy test at 2nd baseline (Visit 8).
- •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 512
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Treatment Period 1
- •1. Use of any hormonal contraceptive method in the prior 3 mths
- •2. Use of depot or injectable hormonal contraception in the prior 6 mths
- •3. History of or diagnosed with psychosis, depression or anxiety as per medical history and interview with the clinician
- •4. Regular use within 6 mths before screening, or current use, of any medication regularly associated with sexual dysfunction or known to affect sexual arousal or desire (per protocol)
- •5. Chronic or acute life stress including planned surgery or other medical procedures that interferes with sexual function or sexual activity
- •6. Androgen therapy, using OTC anabolic steroids within 3 mths prior to screening, topical testosterone within 7 days before screening
- •7. Moderate, severe or cystic acne; clinically significant hirsutism; male pattern hair loss
- •8. Hyperandrogenic conditions (per protocol)
- •9. Lactation, pregnancy; or status post-partum or post-abortion within 6 mths before screening; intention to become pregnant during the study
- •10. Abnormal cervical smear (except: ASCUS with negative reflex HPV test)
- •11. Clinically significant abnormal laboratory results at screening in the opinion of the investigator, including fasting serum glucose
- •12. History of, or diagnosed with alcohol or drug abuse within 12 mths before screening
- •13. Any arterial hypertension defined by blood pressure values of a) systolic blood pressure = 140 mmHg and /or b) diastolic blood pressure = 90 mmHg
- •14. Diabetes mellitus, systemic lupus erythematosus; chronic inflammatory bowel disease, dyslipoproteinemia requiring active treatment with antilipidemic agent, hemolytic uremic syndrome, sickle cell disease, Sydenham’s chorea
- •15. Contraindication and risks for contraceptive steroids (per protocol)
- •16. Treatment with anticoagulants during the study and within 2 weeks before screening
- •17. Use of any drug within 2 weeks before screening potentially triggering interactions with COC
- •18. Any disease or condition that could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational products (IPs)
- •19. Has any urologic or gynecologic condition that may, in the investigator’s opinion, affect sexual activity and/or function
- •20. Uncontrolled thyroid disorders or abnormal clinically significant TSH at screening
- •21. AST and/or ALT results = 1.5 x ULN or total serum bilirubin > 1.5 x ULN at screening
- •22. = 3 recurrent vaginal or urinary infection within 1 year prior to screening
- •23. Malignant disease except well treated squamous or basal cell cancer of the skin
- •24. Severe renal condition or eGFR <60 mL/min at screening
- •25. Galactose, fructose, lactose intolerance
- •26. Subjects who have used any investigational drug in any clinical trial within 3 mths prior to the first dose of COC or within five-times the half-life period of the drug used in previous study, whichever is longer
- •27. Positive UDS at screening
- •Treatment Period 2
- •1. Development of another female sexual dysfunction that predominates clinically over HSDD secondary to hormonal contraceptive use
- •2. Use of any other hormonal contraceptive method or hormonal medications other than the dispensed LNG/EE study drug in the treatment period 1
- •3. Development of psychosis, depression or anxiety; or another psychiatric disorder or new life stress that interferes with sexual function/ activity during treatment period 1
- •4. Initiation of any medication during treatment period 1 that interferes with se
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