Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT02101203
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet all of the following criteria:
1. Provision of written informed consent
2. Females between 21 and 70 years of age, inclusive, pre or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder \[FSAD\] and/or female orgasmic disorder \[FOD; only as secondary diagnosis\] is allowed). The diagnosis of HSDD will be established by a trained health care professional.
3. Maladaptive activity of sexual inhibitory mechanism(s) (see appendix 4 for definition)
4. Be involved in a stable relationship and have a partner who will be at home for the majority of the study duration
5. Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible to participate in the study:
Cardiovascular Conditions
1. Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
2. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure \> 90 mmHg. For subjects ≥ 60 years old and without diabetes mellitus, familial hypercholesterolemia, or cardiovascular disease: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg
3. Systolic blood pressure ≤ 90 mmHg and/or diastolic blood pressure ≤ 50 mmHg Gynecological and Obstetric Conditions
4. Use of any contraceptive containing anti-androgens (e.g. Cyproteron acetate) or (anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel)
5. Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 μg/day of estrogen
6. Positive test result for Chlamydia or gonorrhea
7. Pregnancy or intention to become pregnant during this study (Note: A urine pregnancy test will be performed in all women of child bearing potential prior to the administration of study medications.)
8. Lactating or delivery in the previous 6 months prior to signing Informed Consent Form
9. Significant abnormal Pap smear in the previous 12 months prior to signing Informed Consent Form
10. History of bilateral oophorectomy
11. Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
12. Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms (e.g. hot flashes, night sweating) in combination with elevated FSH levels (\>40 IU/L) for women from age 40 onwards; in women with a history of hysterectomy perimenopausality can be assessed by FSH levels (\>40 IU/L) and/or vasomotor symptoms Other Medical Conditions
13. Liver and/or renal insufficiency (aspartate aminotransferase, alanine aminotransferase and gamma glutamyltransferase \> 3 times the upper limit of normal and/or estimated glomerular filtration rate (eGFR) \< 60.00 mL/min based on the Cockcroft Gault formula)
14. Any current endocrine disease or endocrinopathy (e.g. uncontrolled thyroid dysfunction) as determined by medical history, basic physical examination and/or laboratory values significantly outside the normal range of the central laboratory; or uncontrolled diabetes mellitus(HbA1c \> 7.5%)
15. Free- and/or total testosterone levels outside the upper limit of the reference range of the central laboratory (free testosterone: \> 1.1 ng/dL, and total testosterone \> 80 ng/dL)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT02101203
Study Brief:
Protocol Section:
NCT02101203