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

NCT00745901 | Completed Phase 4 Results

• 1 other identifier: CR015055
• Study Type: interventional
• Target: 355
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Contraception

Keywords

contraception; bleeding; cycle control

Outcome Measures

Primary Outcomes (19)

• 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)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

  Cycle 1 (Day 8 to Day 28)

• 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.

  Cycle 2 (day 29 to Day 56)

• 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.

  Cycle 3 (Day 57 to Day 84)

• 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.

  Cycle 1 to 3 (Day 8 to Day 84)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (1)

• Patient Satisfaction - Overall

  Cycle 1 to Cycle 3

Interventions

Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC: lead

Related Publications (1)

• 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.

  PMID: 19935020 RESULT

Related Links

• 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

MeSH Terms

Conditions

Hemorrhage

Interventions

norgestimate; Ethinyl Estradiol; drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: North America Pharmaceutical (Ortho-McNeil Janssen Scientific Affairs, LLC)

1-888-526-5060

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 19, 2019
• Results First Posted: May 25, 2010

Record last verified: 2012-12