Phase 3 N=420 Randomized Single-blind Treatment

Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

Dysmenorrhea

Bottom Line

View on ClinicalTrials.gov: NCT00461305 ↗

Enrolled (actual)

420

Serious AEs

1.2%

Results posted

Oct 2010

Primary outcome: Primary: Number of Participants With Intracyclic Bleeding at Cycle 6 — 40; 4 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: DRSP 3 mg/EE 20 µg (13 cycles) (Drug); DRSP 3 mg/EE 30 µg (6 cycles) (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: Female
Sponsor: Bayer
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Intracyclic Bleeding at Cycle 6	40; 4	—
SECONDARY Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6	5; 2; 22; 3; 41; 8	—
SECONDARY Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13	4; 22; 47; 68; 44; 32	—
SECONDARY Distribution of Total Dysmenorrhea Score at Cycle 6	65; 13; 79; 16; 49; 9	—
SECONDARY Distribution of Total Dysmenorrhea Score at Cycle 13	73; 66; 41; 24; 24; 13	—
SECONDARY Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6	75; 14; 119; 19; 59; 16	—
SECONDARY Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13	78; 106; 47; 11	—
SECONDARY Distribution of Severity of Lumbago During Menstruation at Cycle 6	154; 21; 88; 29; 26; 2	—
SECONDARY Distribution of Severity of Lumbago During Menstruation at Cycle 13	148; 72; 19; 3	—
SECONDARY Distribution of Severity of Headache During Menstruation at Cycle 6	187; 37; 41; 4; 29; 11	—
SECONDARY Distribution of Severity of Headache During Menstruation at Cycle 13	168; 38; 30; 6	—
SECONDARY Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6	251; 51; 14; 1; 4; 2	—
SECONDARY Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13	229; 11; 2; 0	—
SECONDARY Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6	202; 34; 52; 13; 11; 4	—
SECONDARY Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13	177; 49; 12; 2; 2; 0	—
SECONDARY Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6	-37.2; -31.9	—
SECONDARY Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13	-41.6	—
SECONDARY Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6	6.7; 12.2	—
SECONDARY Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13	6.2	—
SECONDARY Number of Any Bleeding Episodes From Cycle 1 to Cycle 6	3.3; 3.4; 3.3; 3.1	—
SECONDARY Number of Any Bleeding Episodes From Cycle 1 to Cycle 13	3.2; 3.5; 3.1; 3.2	—
SECONDARY Number of Any Bleeding Days From Cycle 1 to Cycle 6	30.7; 28.9; 19.3; 19.9	—
SECONDARY Number of Any Bleeding Days From Cycle 1 to Cycle 13	30.6; 19.8; 21.2; 17.7	—
SECONDARY Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6	94; 19; 38; 8; 45; 8	—
SECONDARY Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13	93; 38; 45; 33; 41; 40	—
SECONDARY Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6	276; 54; 310; 57; 302; 58	—
SECONDARY Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13	274; 314; 307; 295; 289; 285	—
SECONDARY Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6	90.3; 89.5; 97.4; 100.0; 91.1; 100.0	—
SECONDARY Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13	90.3; 97.4; 91.1; 87.9; 87.8; 92.5	—
SECONDARY Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6	90.1; 87.0; 90.8; 94.7; 91.2; 87.9	—
SECONDARY Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13	90.1; 90.8; 91.2; 92.2; 92.7; 90.9	—
SECONDARY Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6	-4.33; -5.50	—
SECONDARY Change in Serum CA-125 From Baseline to Cycle 13	-4.66	—
SECONDARY Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6	0.159; 0.000	—
SECONDARY Change in Serum CRP From Baseline to Cycle 13	0.014	—

Summary

The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety

Eligibility Criteria

Inclusion Criteria

Patients aged 20 years or older at obtaining informed consent
Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment
Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment

Exclusion Criteria

Patients with ovarian chocolate cysts
Patients with fibroid needed to be treated
Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer
Patients with undiagnosed abnormal vaginal bleeding
Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease 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 prodromata
Patients with pulmonary hypertension or valvular heart disease
Patients who are regularly taking nutritional products that contain St. John's Wort
Patients who underwent surgical treatment for endometriosis within 2 months prior to screening
Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00461305). 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.