Trial Outcomes & Findings for Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea (NCT NCT00517556)

Results Overview

Change in subjective perception of pain, as measured by the VAS. Subjects completed the VAS at baseline and 6 months. The VAS ranges from 0 (no pain) to 100 (worst pain). Therefore, a negative change in VAS indicates improvement in pain and a positive change in VAS indicates worsening of pain.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2017-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Study Group (CCOCP) treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles	Control Group (Traditional OCP) treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
Overall Study STARTED	19	19
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group (CCOCP) n=19 Participants treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles	Control Group (Traditional OCP) n=19 Participants treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.	Total n=38 Participants Total of all reporting groups
Age, Continuous	20.47 years STANDARD_DEVIATION 3.91 • n=5 Participants	21.00 years STANDARD_DEVIATION 4.03 • n=7 Participants	20.74 years STANDARD_DEVIATION 3.92 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Croatia	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants
BMI	21.20 kg/m^2 STANDARD_DEVIATION 3.23 • n=5 Participants	20.36 kg/m^2 STANDARD_DEVIATION 1.77 • n=7 Participants	20.78 kg/m^2 STANDARD_DEVIATION 2.60 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Change in subjective perception of pain, as measured by the VAS. Subjects completed the VAS at baseline and 6 months. The VAS ranges from 0 (no pain) to 100 (worst pain). Therefore, a negative change in VAS indicates improvement in pain and a positive change in VAS indicates worsening of pain.

Outcome measures

Outcome measures
Measure	Study Group (CCOCP) n=19 Participants treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles	Control Group (Traditional OCP) n=19 Participants treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
Change in Visual Analog Scale (VAS) Score	-74.8 units on a scale Interval -86.1 to -63.5	-58.7 units on a scale Interval -70.3 to -47.2

Adverse Events

Study Group (CCOCP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group (Traditional OCP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard S. Legro, M.D.

The Milton S. Hershey Medical Center

Phone: 717-531-6210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place