A Phase 3 Placebo-controlled, Double-blind, Randomized, Parallel-group Study to Evaluate the Efficacy in Primary and Secondary Dysmenorrhea and the Long-term Safety of DSG/EE 150/20 using a Flexible Extended Regimen of Administration (DSG/EE 150/20)
The Efficacy of DSG/EE 150/20 in Primary and Secondary Dysmenorrhea using a Flexible Extended Regimen (FREEDOM 150/20)
Kuwahara Chiaki
IQVIA Services Japan G.K.
4-10-18 Takanawa, Minato-ku, Tokyo
+81-3-6859-9500
OG-8276A_FL@iqvia.com
jRCT Inquiry Receipt Center
IQVIA Services Japan G.K.
4-10-18 Takanawa, Minato-ku, Tokyo
+81-3-6859-9500
OG-8276A_FL@iqvia.com
Not Recruiting
July. 13, 2023
July. 21, 2023
224
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
treatment purpose
1. Aged 16 years or older at the time of obtaining consent
-When the participant is below the age of 18 years, voluntary agreement shall be obtained from the participant and the representative or legal guardian, using the assent (for the minor) and ICF (for the representative or legal guardian).
2.Has a history of regular menstrual cycles of 28 +- 7 days when not using hormonal products
3.Diagnosed with moderate to severe primary or secondary dysmenorrhea:
-Primary dysmenorrhea
-secondary dysmenorrhea ruled out by interview, internal examination, and transvaginal ultrasonography
-Secondary dysmenorrhea
-Dysmenorrhea due to endometriosis, adenomyosis or uterine fibroids:
- confirmed diagnosis of endometriosis or adenomyosis by laparotomy or laparoscopy
- diagnosed with endometriosis (with ovarian chocolate cysts), adenomyosis or uterine fibroids by transvaginal ultrasonography (at the time of screening)
4.Has dysmenorrhea during the screening period as defined by a Total Dysmenorrhea Score of 3 or higher, as recorded by the participant in the e-diary after completion of the baseline cycle
5.Does not wish to become pregnant during the trial and use condoms correctly and consistently for contraception
6.Is able and willing (in the opinion of the investigator) to adhere to all required study procedures, including study visits and e-Diary entries, and not planning to relocate during the study (such that the participant would not be able to continue participation at the study site)
1. Has sex steroid-influenced malignancies (eg, of the genital organs or the breasts)
2. Has undiagnosed genital bleeding
3. Has a presence or history of venous or arterial thrombosis (conditions such as deep vein thrombosis, pulmonary embolism, cerebrovascular disorder, coronary artery disease)
4. Is a smoker and aged 35 years or more
5. Has migraine with aura (scintillating dark spots, star-shaped flashes, etc.)
6. Has one severe or multiple risk factors for venous or arterial thrombosis such as major surgery with prolonged immobilization (within 2 weeks before screening, eg, due to trauma, surgery, or other illness markedly limiting mobility), valvular heart disease with complications (pulmonary hypertension, history of subacute bacterial endocarditis), atrial fibrillation, uncontrolled hypertension, obesity, dyslipoproteinemia, and increasing age
7. Has diabetes with vascular lesions (diabetic nephropathy, diabetic retinopathy, etc.)
8. Has known thrombophilia (activated protein C resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, etc.)
9. Has antiphospholipid antibody syndrome
10. Has severe liver dysfunction
Note: Participant has a presence or history of clinically significant liver disease, including active viral hepatitis or cirrhosis. Participants with a prior history of liver disease which is now inactive or successfully treated may be eligible if liver function values (ie, AST, ALT, TBL) have been normal for the past year and are within the normal range (per central laboratory) at screening.
11. Has a presence or history of liver tumors (benign or malignant)
12. Has pancreatitis or a history thereof associated with severe hypertriglyceridemia
13. Has any disease that may worsen under hormonal treatment such as disturbances in the bile flow (presence of or history of cholestasis, presence of gallstones), systemic lupus erythematosus, pemphigoid gestationis or idiopathic icterus during a previous pregnancy, middle-ear deafness (otosclerosis), Sydenham chorea, or porphyria
14. Has untreated gonorrhea, chlamydia, or trichomonas
Note: Participants may be rescreened 3 weeks after completing treatment for these conditions if not at risk for reinfection as deemed by the investigator.
15. Has no documented normal PAP test within the timeline of current standard of care guidelines or has a significantly abnormal PAP test at screening (ie, ASC-H, high grade squamous intraepithelial lesion, atypical glandular cells [any type], squamous cell carcinoma, or adenocarcinoma [in situ or invasive])
Note: The presence of atypical squamous cells of undetermined significance (ASCUS) will require human papillomavirus (HPV) reflex testing; ASCUS in an HPV-negative participant is not exclusionary. The presence of high-risk HPV, regardless of PAP result, is exclusionary.
16. Is within 4 weeks after childbirth
17. Intends to become pregnant during study participation or has a known or suspected pregnancy or has a positive B-hCG or urine pregnancy test
18. Is breastfeeding
19. Has hypersensitivity to any of the active substances of study drug, or to any of the excipients
20. Who regularly uses medicinal or herbal products that induce microsomal enzymes, specifically cytochrome P450 (CYP) enzymes such as phenytoin, phenobarbital, primidone, bosentan, carbamazepine, rifampicin, and herbal remedy St. John's wort
21. Who has received the following drugs within 2 months before screening
- Estrogens, progestins, including hormonal contraceptives
- Luteinizing Hormone-, Follicle Stimulating Hormone-, and gonadotropin releasing hormone (GnRH)-analogues
- Testosterone derivatives, aromatase inhibitors
22. Using an intrauterine device (IUD)
23. Underwent transvaginal ethanol sclerotherapy, laparotomy, or laparoscopic (laparoscopy) surgical treatment within 2 months prior to screening
24. Uses analgesics regularly for purposes other than the treatment of dysmenorrhea during the clinical trial period
25. Participated in an investigational drug or device study within 3 months prior to screening
26.Is judged by the investigator to be inappropriate
16age old over
No limit
Female
primary or secondary dysmenorrhea
<Treatment, consisting of the efficacy phase (the equivalent of 3 conventional cycles)> participants will be randomized in a 3:1 ratio to DSG/EE 150/20 or to visually matching placebo.
Participants will take one DSG/EE 150/20 or placebo tablet daily from Day 1 to any day between Day 24 and Day 80, followed by 4 consecutive days without tablet intake (tablet-free interval, TFI). Scheduling the 4 days TFI depends on the participant's wish to schedule or postpone a withdrawal bleeding. 1 Cycle lengths range between 28 days (24/4) and 84 days (80/4).
<treatment extension phase (up to the equivalent of 10 conventional cycles)> Participants will take one DSG/EE 150/20 tablet daily from Day 1 to any day between Day 24 and Day 80, followed by 4 consecutive days without tablet intake (tablet-free interval, TFI). Scheduling the 4 days TFI depends on the participant's wish to schedule or postpone a withdrawal bleeding. 1 Cycle lengths range between 28 days (24/4) and 84 days (80/4).
Change from baseline through Day 84 in dysmenorrhea, as measured by the Total Dysmenorrhea Score.
