Phase 4 N=355 Randomized Treatment

Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT00745901 ↗

Enrolled (actual)

355

Serious AEs

0.9%

Results posted

May 2010

Primary outcome: Primary: Number of Days of Unscheduled Blood Loss - Cycle 1 — 1.9; 2.0 Days — p=0.9698

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Days of Unscheduled Blood Loss - Cycle 1	1.9; 2.0	0.9698
PRIMARY Number of Days of Unscheduled Blood Loss - Cycle 2	1.3; 1.9	0.0050 sig
PRIMARY Number of Days of Unscheduled Blood Loss - Cycle 3	1.4; 2.4	0.0006 sig
PRIMARY Overall Number of Days of Unscheduled Blood Loss	4.6; 6.1	0.0031 sig
PRIMARY Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes	55; 29; 46; 41; 23; 50	0.0013 sig
PRIMARY Number of Days of Scheduled Blood Loss - Cycle 1	4.3; 3.2	<0.0001 sig
PRIMARY Number of Days of Scheduled Blood Loss - Cycle 2	4.0; 2.8	<0.0001 sig
PRIMARY Number of Days of Scheduled Blood Loss - Cycle 3	3.1; 1.2	<0.0001 sig
PRIMARY Overall Number of Days of Scheduled Blood Loss	11.2; 7.0	<0.0001 sig
PRIMARY Number of Days of Total Blood Loss - Cycle 1	6.2; 5.2	0.0033 sig
PRIMARY Number of Days of Total Blood Loss - Cycle 2	5.3; 4.6	0.0060 sig
PRIMARY Number of Days of Total Blood Loss - Cycle 3	4.6; 3.6	<0.0001 sig
PRIMARY Overall Number of Days of Total Blood Loss	15.8; 13.2	<0.0001 sig
PRIMARY Number of Participants With Unscheduled Bleeding Cycle 1	72; 74	0.912
PRIMARY Number of Participants With Unscheduled Bleeding Cycle 2	57; 87	0.003 sig
PRIMARY Number of Participants With Unscheduled Bleeding Cycle 3	65; 94	0.002 sig
PRIMARY Number of Participants With Breakthrough Bleeding/Spotting Cycle 1	53; 56	0.816
PRIMARY Number of Participants With Breakthrough Bleeding/Spotting Cycle 2	39; 62	0.012 sig
PRIMARY Number of Participants With Breakthrough Bleeding/Spotting Cycle 3	47; 74	0.003 sig
SECONDARY Patient Satisfaction - Overall	159; 162; 99; 115; 35; 32	0.0715

Summary

The purpose of this study in healthy sexually active females is to evaluate the cycle control with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00745901). 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.