Hypoactive sexual desire disorder (HSDD) secondary to combined oral contraception use. MedDRA version: 20.0 Level: LLT Classification code 10020933 Term: Hypoactive sexual desire disorder System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Microgynon 21, 30 µg + 150 µg, film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ETHINYLESTRADIOL
CAS Number: 57-63-6
Concentration unit: µg microgram(s)
Con
Sponsors
Gedeon Richter Plc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of DHEA (50 mg daily dose) relative to placebo in women with COC-associated distressing loss of sexual desire (HSDD secondary to COC use) as measured by Profile of Female Sexual Function (PFSF) Desire Domain.;Secondary Objective: • To evaluate self reported perception of low desire (Female Sexual Distress Scale-Revised [FSDS-R] item 13) • To evaluate subjects treatment benefit • To validate in a nested study PFSF: total scores and single items of PFSF for example: - Factor analysis - Construct validity (to include convergent validity and known-groups validity) - Reliability of the PFSF domains - Responsiveness of the PFSF domains - Responder definition for the PFSF Desire Domain through an anchor-based approach using Patient Global Impression of Change (PGIC) question and Subject's Meaningful Benefit Question as anchors - Verification/test whether previously published threshold of 5 or less indicates low desire on the PFSF Desire Domain by use of receiver operating characteristic (ROC) curve analysis. • To evaluate effect of DHEA-S treatment on endocrine parameters as a variable of restored sexual desire ;Primary end point(s): PFSF Desire Domain, change from baseline;Timepoint(s) of evaluation of this end point: Change from treatment period 2 baseline to Day 168 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • FSDS-R item 13, change from baseline • Proportion of subjects answering the Patient’s Meaningful Benefit Question as “yes” • PFSF Responsiveness domain, change from baseline • PFSF Arousal domain, change from baseline • PFSF Orgasm domain, change from baseline • PFSF Pleasure domain, change from baseline • PFSF Concerns domain, change from baseline • PFSF Self-image domain, change from baseline • PFSF total score, change from baseline • Endocrine parameters: absolute levels and change from screening to final cycle in treatment period 1 and change from final cycle in treatment period 1 to final cycle in treatment period 2, correlation with efficacy parameters ;Timepoint(s) of evaluation of this end point: Change from treatment period 2 baseline to Day 168 Endocrine timepoints: Change from screening to final cycle in treatment period 1 and change from final cycle in treatment period 1 to final cycle in treatment period 2 | — |
Countries
Bulgaria, Czechia, Czech Republic, Germany, Hungary, Netherlands, Poland, Romania
Contacts
Public ContactMedicalInformationScientificService
Gedeon Richter Plc.
Outcome results
None listed