Phase 3
N=249
SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
Dysmenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT00511797 ↗Enrolled (actual)
249
Serious AEs
1.6%
Results posted
Oct 2010
Primary outcome: Primary: Change From Baseline in Total Dysmenorrheal Score at Final Evaluation — -2.5; -2.1; -1.9; -1.0 scores on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SH T04740B (Drug); SH T00186DF (Drug); SH T04740F (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Bayer
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Dysmenorrheal Score at Final Evaluation |
-2.5; -2.1; -1.9; -1.0 | <0.001 sig |
| SECONDARY Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4 |
-2.4; -2.1; -1.8; -0.8; -2.1; -2.3 | <0.001 sig |
| SECONDARY Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4 |
15; 17; 11; 3; 28; 27 | — |
| SECONDARY Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4 |
34; 36; 30; 18; 15; 12 | — |
| SECONDARY Number of Participants With Severity of Headache During Menstruation at Cycle 4 |
47; 35; 39; 29; 5; 10 | — |
| SECONDARY Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4 |
51; 47; 47; 40; 2; 4 | — |
| SECONDARY Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4 |
40; 41; 42; 30; 11; 10 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4 |
-43.0; -39.5; -31.8; -10.3 | — |
| SECONDARY Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4 |
5.9; 5.4; 4.0; 11.5 | — |
| SECONDARY Change From Baseline in Endometrial Thickness After 4-cycle Treatment |
-5.5; -7.1; -6.3; -0.1 | — |
| SECONDARY Number of Bleeding / Spotting Episodes |
3.3; 3.3; 3.4; 2.9; 0.5; 0.4 | — |
| SECONDARY Number of Bleeding / Spotting Days |
32.3; 31.2; 29.2; 22.6; 21.3; 19.3 | — |
| SECONDARY Participants With Withdrawal Bleeding |
50; 50; 49; 47 | — |
| SECONDARY Participants With Intracyclic Bleeding |
14; 8; 8; 4 | — |
| SECONDARY Participants With Non-heavy Intracyclic Bleeding |
14; 8; 7; 2 | — |
| SECONDARY Participants With Non-heavy Withdrawal Bleeding |
45; 44; 42; 38 | — |
| SECONDARY Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment |
-2.78; 0.53; -3.79; 0.89 | — |
| SECONDARY Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment |
0.015; 0.042; -0.014; -0.175 | — |
| SECONDARY Change From Baseline in Serum Estradiol Level After 4-cycle Treatment |
-18.32; -42.23; -98.02; 49.20 | — |
| SECONDARY Change From Baseline in Serum Progesterone Level at Cycle 4 |
-7.93; -8.23; -9.37; -0.27 | — |
Summary
The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.
Eligibility Criteria
Inclusion Criteria
- Patients aged 20 years or older at obtaining informed consent
- Patients having the normal menstrual cycle (28+/-3 days) in the latest two menses before the final enrollment
- Patients having a total dysmenorrhea score of at least 3 points in two menstrual cycles before the final enrollment
Exclusion Criteria
- Patients with ovarian chocolate cysts and symptomatic uterine fibroids (as defined in greater detail in the study protocol)
- Patients with estrogen-dependent tumors (e.g. breast cancer, cancer of the uterine body or breast fibrocystic, etc.), and patients with cervical cancer or suspected cervical cancer (e.g. class III or greater in the cervical smear or endometrial smear examination.)
- Patients with undiagnosed abnormal vaginal bleeding
- Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease(including transient ischemic attack, etc.), or coronary artery disease(e.g. myocardial infarction and angina pectoris, etc.), or a history of those diseases
- Patients aged 35 years or older who smoke at least 15 cigarettes per day
- Patients with migraine accompanied by prodrome (e.g. scintillating scotoma or star-shaped scintillation)
- Patients with pulmonary hypertension or valvular heart disease complicated by atrial fibrillation, and patients with a history of subacute bacterial endocarditis
- Patients who are regularly taking nutritional products that contain St. John's Wort
- Patients who underwent surgical treatment for endometriosis by laparotomy, or laparoscopy within 2 months prior to screening
- Patients who need to use analgesics regularly for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)
Data sourced from ClinicalTrials.gov (NCT00511797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.