Study to Evaluate Cycle Control With Norgestimate/Ethinyl... | NCT00745901

Description Module

Detailed Description

This is a randomized, open-label, active-controlled, multicenter study in healthy sexually active females to evaluate cycle control with norgestimate/ethinyl estradiol versus drospireneone/ethinyl estradiol. The Open-Label Treatment Phase will last for three 28-day cycles. Approximately 300 patients will be randomized in a 1:1 fashion according to a predetermined randomization schedule. Patients will be seen for a baseline visit (Visit 1) up to 35 days prior to dosing to obtain informed consent, have a physical examination including a breast exam, height and weight, vital signs, a Chlamydia test and a urine pregnancy test performed, and to give their medical history. Patients will be instructed to report bleeding data using an interactive voice response system (IVRS) based diary on a daily basis. Patients will be instructed to continue taking 1 pill each day for 3 cycles, record this information daily in the IVRS and to contact the study site if they have any questions or adverse events they would like to discuss. The final study visit (Visit 2) will occur on Day 8 after completing 3 cycles of study medication. Patients will be weighed, have vital signs performed, report any adverse events and or changes in concomitant medications, and complete the satisfaction questionnaire at the final visit. Safety will be assessed by physical examinations, adverse events, body weight and vital signs. Patients randomized to drospireneone/ethinyl estradiol and taking any medication that could increase serum potassium levels (as outlined in the Package Insert) will also have their potassium level checked during their first cycle of treatment (Days 15 to 28 of treatment). Three 28-day cycles of either norgestimate/ethinyl estradiol or drospirenone/ethinyl estradiol.

Name	Type	Description	Arm Group Labels	Other Names
Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Days of Unscheduled Blood Loss - Cycle 1	cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.	Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
Number of Days of Unscheduled Blood Loss - Cycle 2	cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.	Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)
Number of Days of Unscheduled Blood Loss - Cycle 3	Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.	Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)
Overall Number of Days of Unscheduled Blood Loss	cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.	Cycle 1 to Cycle 3 (Day 8 to Day 80)

Secondary Outcomes

Measure	Description	Time Frame
Patient Satisfaction - Overall	patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied.	Cycle 1 to Cycle 3

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy females who want oral contraception
No cervical or vaginal abnormalities on gynecological examination
Negative Chlamydia test
Pap smear without evidence of moderate or severe dysplasia or any malignancy within the preceding 12 months
Negative urine pregnancy test conducted during Visit 1
One normal menstrual period in 35 days prior to Visit 1
Regular menstrual cycles (every 26-35 days)
Last term pregnancy at least 42 days prior to Visit 1, and have had at least one normal menstrual period (typical in duration and amount of flow for the subject) since her last pregnancy
Post-menarcheal and pre-menopausal
At least one normal menstrual period (typical in duration and amount of flow for the subject) since having undergone uterines urgery or removal of an IUD, Norplant, DepoProvera or other hormonal injectables or implants.

Exclusion Criteria:

History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy
Previously discontinued ORTHO TRI-CYCLEN LO or YAZ due to breakthrough bleeding
Pregnant or lactating
Body mass index (BMI) of >40kg/m2
Clinical evidence of carcinoma or other malignancy (history of basal cell carcinoma of the skin is not exclusionary)
History of alcohol or drug abuse in the investigator's judgment based on history and physical examination (within 12 months prior to Visit 1)
Significant depression or psychiatric disease in the investigator's judgment based on history and physical examination which would result in an unreliable patient
Patient deemed by the investigator to have questionable reliability in her ability to comply with the protocol and provide accurate information
Have any medical condition or planned surgical procedure which, in the opinion of the investigator, may be exacerbated by treatment with study medication or a patient receiving any concurrent therapy that could be affected by treatment with study medication
Disallowed therapies: currently taking therapeutic anticoagulants (e.g,. Coumadin, Heparin) or have a bleeding disorder (e.g. von Willebrand's Disease), DepoProvera or other hormonal injectables in the six months before Visit 1, currently have Norplant or other hormonal implants in place, or have had removal of Norplant within 60 days prior to Visit 1, used a steroid-containing IUD within 3 months prior to Visit 1
Or current use of an IUD
Consistently elevated blood pressure defined as sitting systolic BP>140 mmHg or diastolic BP>90 mmHg
Have an untreated thyroid disorder in the investigator's judgment based on history and physical examination
unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
Patients who in the opinion of the investigator should not be enrolled in the study based on the product labeling for ORTHO TRI-CYCLEN LO and YAZ including potential drug-drug interactions
Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment

Name	Affiliation	Role
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial	Ortho-McNeil Janssen Scientific Affairs, LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
19935020	Result	Kaunitz AM, Burkman RT, Fisher AC, LaGuardia KD. Cycle control with a 21-day compared with a 24-day oral contraceptive pill: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1205-1212. doi: 10.1097/AOG.0b013e3181beab47.

Label	URL
An Open-Label Study to Evaluate Cycle Control with ORTHO TRI-CYCLEN LO (norgestimate/ethinyl estradiol) and YAZ (drospirenone/ethinyl estradiol) in Healthy, Sexually Active Females	View source

ID	Title	Description
FG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
FG001	DRSP/20mcg EE

ID	Title	Description
BG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
BG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000178 BG001177 BG002355

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Days of Unscheduled Blood Loss - Cycle 1

cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.

Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.

Posted

Mean

Standard Deviation

Days

Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000165 OG001167

Title

Denominators

Categories

Title	Measurements
	OG0001.9± 3.14 OG0012.0± 3.53

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wilcoxon (Mann-Whitney)		0.9698							95							Superiority or Other

Secondary

Patient Satisfaction - Overall

patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied.

Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.

Posted

Number

Participants

Cycle 1 to Cycle 3

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Primary

Number of Days of Unscheduled Blood Loss - Cycle 2

cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.

Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.

Posted

Mean

Standard Deviation

Days

Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants

Primary

Number of Days of Unscheduled Blood Loss - Cycle 3

Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.

Posted

Mean

Standard Deviation

Days

Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants

Primary

Overall Number of Days of Unscheduled Blood Loss

cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.

Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.

Posted

Mean

Standard Deviation

Days

Cycle 1 to Cycle 3 (Day 8 to Day 80)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants

Primary

Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes

Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day.

Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.

Posted

Number

Participants

Cycle 1 to Cycle 3 (Day 8 to Day 80)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Primary

Number of Days of Scheduled Blood Loss - Cycle 1

cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.

Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.

Posted

Mean

Standard Deviation

Days

Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants

Primary

Number of Days of Scheduled Blood Loss - Cycle 2

cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.

Posted

Mean

Standard Deviation

Days

Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants

Primary

Number of Days of Scheduled Blood Loss - Cycle 3

cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.

Posted

Mean

Standard Deviation

Days

Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants

Primary

Overall Number of Days of Scheduled Blood Loss

summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.

Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.

Posted

Mean

Standard Deviation

Days

Cycle 1 to Cycle 3 (Day 8 to Day 84)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants

Primary

Number of Days of Total Blood Loss - Cycle 1

cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.

Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.

Posted

Mean

Standard Deviation

Days

Cycle 1 (Day 8 to Day 28)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Primary

Number of Days of Total Blood Loss - Cycle 2

cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.

Posted

Mean

Standard Deviation

Days

Cycle 2 (day 29 to Day 56)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Primary

Number of Days of Total Blood Loss - Cycle 3

cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.

Posted

Mean

Standard Deviation

Days

Cycle 3 (Day 57 to Day 84)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Primary

Overall Number of Days of Total Blood Loss

cycle control between treatment groups, overall. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.

Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.

Posted

Mean

Standard Deviation

Days

Cycle 1 to 3 (Day 8 to Day 84)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Primary

Number of Participants With Unscheduled Bleeding Cycle 1

Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.

Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.

Posted

Number

Participants

Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Primary

Number of Participants With Unscheduled Bleeding Cycle 2

Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.

Posted

Number

Participants

Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Primary

Number of Participants With Unscheduled Bleeding Cycle 3

Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.

Posted

Number

Participants

Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Primary

Number of Participants With Breakthrough Bleeding/Spotting Cycle 1

Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.

Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.

Posted

Number

Participants

Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Primary

Number of Participants With Breakthrough Bleeding/Spotting Cycle 2

Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.

Posted

Number

Participants

Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Primary

Number of Participants With Breakthrough Bleeding/Spotting Cycle 3

Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle.

Posted

Number

Participants

Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)

ID	Title	Description
OG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
OG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acne	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0013 affected167 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Anxiety disorder	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0012 affected167 at risk
Breast tenderness	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected167 at risk EG0010 affected167 at risk
Breast enlargement	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Bronchitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Dysmenorrhea	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0012 affected167 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0011 affected167 at risk
Genital herpes	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected167 at risk EG0012 affected167 at risk
Hypothyroidism	Endocrine disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Irritability	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0014 affected167 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Libido decreased	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Liposuction	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Localised infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Mood swings	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected167 at risk EG0015 affected167 at risk
Migraine	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Mood altered	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected167 at risk EG0011 affected167 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected167 at risk EG0010 affected167 at risk
Palpitations	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Panic disorder	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Pelvic hemorrhage	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Periorbital cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Polydipsia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Sinusitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected167 at risk EG0010 affected167 at risk
Sinus headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Tension headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected167 at risk EG0011 affected167 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Vaginal cyst	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Vaginal hemorrhage	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Vision blurred	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected167 at risk EG0011 affected167 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0011 affected167 at risk
Vulval abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0010 affected167 at risk
Weight increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected167 at risk EG0012 affected167 at risk

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C017576	norgestimate
D004997	Ethinyl Estradiol
C534342	drospirenone and ethinyl estradiol combination

ID	Term
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D042782	Estrogenic Steroids, Alkylated
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NGM/25mcg EE	NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients			2	167	34	167
EG001	DRSP/20mcg EE	DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients			1	167	34	167