The Oral Contraceptive Pill for Premenstrual Worsening of Depression

• ClinicalTrials.gov Identifier: NCT00633360
• Recruitment Status: Completed
• First Posted: March 12, 2008
• Results First Posted: March 20, 2017
• Last Update Posted: March 20, 2017
• Sponsor: Massachusetts General Hospital
• Collaborator: Bayer
• Information provided by (Responsible Party): Hadine Joffe, MD, Brigham and Women's Hospital

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Conditions: Premenstrual Syndrome; Depression
• Interventions: Drug: Drospirenone and ethinyl estradiol; Drug: Placebo
• Enrollment: 32

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Drospirenone and Ethinyl Estradiol	Placebo
Arm/Group Description	Drospirenone and ethinyl estradiol Drospirenone and ethinyl estradiol: Once daily by mouth	Placebo Placebo: Once daily by mouth
Period Title: Overall Study
Started	16	16
Completed	12	13
Not Completed	4	3
Reason Not Completed
Lost to Follow-up	1	1
Adverse Event	3	1
Protocol Violation	0	1

Baseline Characteristics

Arm/Group Title		Drospirenone and Ethinyl Estradiol	Placebo	Total
Arm/Group Description		Drospirenone and ethinyl estradiol Drospirenone and ethinyl estradiol: Once daily by mouth	Placebo Placebo: Once daily by mouth	Total of all reporting groups
Overall Number of Baseline Participants		16	16	32
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	16 participants	16 participants	32 participants
		28.1 (7.3)	26.3 (7.1)	27.2 (7.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	16 participants	16 participants	32 participants
	Female	16 100.0%	16 100.0%	32 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	16 participants	16 participants	32 participants
		16	16	32

Outcome Measures

1. Primary Outcome

Title	Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)
Description	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.
Time Frame	Baseline and 2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drospirenone and Ethinyl Estradiol	Placebo
Arm/Group Description:	Drospirenone and ethinyl estradiol Drospirenone and ethinyl estradiol: Once daily by mouth	Placebo Placebo: Once daily by mouth
Overall Number of Participants Analyzed	12	13
Median (Inter-Quartile Range); Unit of Measure: percent change
	-43.6; (-73.8 to -24.6)	-38.9; (-61.5 to 0.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Drospirenone and Ethinyl Estradiol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.59
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

2. Secondary Outcome

Title	Percent Change in Daily Record of Severity of Problems (DRSP)
Description	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.
Time Frame	Baseline and 2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drospirenone and Ethinyl Estradiol	Placebo
Arm/Group Description:	Drospirenone and ethinyl estradiol	Placebo
Overall Number of Participants Analyzed	12	13
Median (Inter-Quartile Range); Unit of Measure: percent change
	-23.5; (-38.4 to -7.0)	-20.9; (-38.7 to -11.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Drospirenone and Ethinyl Estradiol, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.29
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Drospirenone and Ethinyl Estradiol		Placebo
Arm/Group Description	Drospirenone and ethinyl estradiol Drospirenone and ethinyl estradiol: Once daily by mouth		Placebo Placebo: Once daily by mouth
All-Cause Mortality
	Drospirenone and Ethinyl Estradiol		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Drospirenone and Ethinyl Estradiol		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0.00%)		0/16 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Drospirenone and Ethinyl Estradiol		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/16 (62.50%)		7/16 (43.75%)
Gastrointestinal disorders
nausea	1/16 (6.25%)	1	3/16 (18.75%)	3
Nervous system disorders
headache	2/16 (12.50%)	2	3/16 (18.75%)	3
Reproductive system and breast disorders
spotting	8/16 (50.00%)	8	1/16 (6.25%)	1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr Hadine Joffe
• Organization: Brigham & Women's Hospital
• Phone: 617-732-4906
• EMail: hjoffe@partners.org

• Responsible Party: Hadine Joffe, MD, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT00633360 History of Changes
• Other Study ID Numbers: 2007-P-002057
• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Results First Submitted: June 24, 2016
• Results First Posted: March 20, 2017
• Last Update Posted: March 20, 2017