A Phase 2, Randomized, Double-blind, Placebo-controlled Proof-of-Concept Study to Evaluate the Efficacy and Safety of Estetrol in Postmenopausal Subjects with Female Sexual Arousal Disorder
Criteria:Subjects who meet all of the following criteria are eligible for the study:
1. Signed and dated written informed consent form and any required privacy authorization prior to the initiation of any study procedure, after the nature of the study has been explained according to local regulatory requirements.
2. ) vasomotor menopausal symptoms.
3. FSAD was diagnosed by an expert and in accordance with DSM-IV-TR, with a total score of greater then or equal to 18 screening.
4. Postmenopausal status defined for hysterectomized subjects as any of the following: Serum FSH >40 mIU/mL and E2 <20 pg/mL (values obtained after washout of estrogen/progestin containing drug, see exclusion criteria 17, 19 and 20). or at least 6 months postsurgical bilateral oophorectomy.
5. Documented hysterectomy (with or without oophorectomy) must have occurred at least 6 months prior to the start of screening. Hysterectomy can be total or subtotal (i.e., cervix was not removed).
6.. A mammogram that shows no sign of significant disease performed during screening or within 9 months prior to the start of screening1 .
8. Have a vagina.
9. Based on clinical interview, subject experienced 'normal' past sexual function.
10. Sexual activity at least two times each month during the last 6 months and agrees to have sexual activity at least two times each month for the duration of the study. Sexual activity can include any activity that may result in sexual stimulation or sexual pleasure e.g., intercourse, caressing, foreplay, masturbation, and oral sex.
11. Good physical and mental health, in the judgement of the investigator as based on medical history, physical and gynecological examination, and clinical assessments performed prior to Visit 1.
12. Able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
13. Able and willing to complete study daily diaries (electronically) and questionnaires.