Trial Outcomes & Findings for The Oral Contraceptive Pill for Premenstrual Worsening of Depression (NCT NCT00633360)

Results Overview

The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and during 2nd treatment month in order to calculate the change in MADRS score.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Baseline and 2 months

Results posted on

2017-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Drospirenone and Ethinyl Estradiol Drospirenone and ethinyl estradiol Drospirenone and ethinyl estradiol: Once daily by mouth	Placebo Placebo Placebo: Once daily by mouth
Overall Study STARTED	16	16
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Drospirenone and Ethinyl Estradiol Drospirenone and ethinyl estradiol Drospirenone and ethinyl estradiol: Once daily by mouth	Placebo Placebo Placebo: Once daily by mouth
Overall Study Lost to Follow-up	1	1
Overall Study Adverse Event	3	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

The Oral Contraceptive Pill for Premenstrual Worsening of Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drospirenone and Ethinyl Estradiol n=16 Participants Drospirenone and ethinyl estradiol Drospirenone and ethinyl estradiol: Once daily by mouth	Placebo n=16 Participants Placebo Placebo: Once daily by mouth	Total n=32 Participants Total of all reporting groups
Age, Continuous	28.1 years STANDARD_DEVIATION 7.3 • n=5 Participants	26.3 years STANDARD_DEVIATION 7.1 • n=7 Participants	27.2 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 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 United States	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2 months

The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and during 2nd treatment month in order to calculate the change in MADRS score.

Outcome measures

Outcome measures
Measure	Drospirenone and Ethinyl Estradiol n=12 Participants Drospirenone and ethinyl estradiol Drospirenone and ethinyl estradiol: Once daily by mouth	Placebo n=13 Participants Placebo Placebo: Once daily by mouth
Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)	-43.6 percent change Interval -73.8 to -24.6	-38.9 percent change Interval -61.5 to 0.0

SECONDARY outcome

Timeframe: Baseline and 2 months

The DRSP is a 24-item self-administered daily dairy that assesses the severity of mood and physical symptoms which occur as part of the premenstrual syndrome and PMDD. Each question is rated on a scale of 1-6 with a total score range from 24-144. A higher score indicates greater symptom burden.

Outcome measures

Outcome measures
Measure	Drospirenone and Ethinyl Estradiol n=12 Participants Drospirenone and ethinyl estradiol Drospirenone and ethinyl estradiol: Once daily by mouth	Placebo n=13 Participants Placebo Placebo: Once daily by mouth
Percent Change in Daily Record of Severity of Problems (DRSP)	-23.5 percent change Interval -38.4 to -7.0	-20.9 percent change Interval -38.7 to -11.7

Adverse Events

Drospirenone and Ethinyl Estradiol

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Drospirenone and Ethinyl Estradiol n=16 participants at risk Drospirenone and ethinyl estradiol Drospirenone and ethinyl estradiol: Once daily by mouth	Placebo n=16 participants at risk Placebo Placebo: Once daily by mouth
Reproductive system and breast disorders spotting	50.0% 8/16 • Number of events 8	6.2% 1/16 • Number of events 1
Gastrointestinal disorders nausea	6.2% 1/16 • Number of events 1	18.8% 3/16 • Number of events 3
Nervous system disorders headache	12.5% 2/16 • Number of events 2	18.8% 3/16 • Number of events 3

Additional Information

Dr Hadine Joffe

Brigham & Women's Hospital

Phone: 617-732-4906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place