ContraceptionPhase 4NCT00745901
Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
A Phase 4 study testing Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol in people with Contraception, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol
- How many people
- 355 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Oct 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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)
Show all 16Show fewer
- 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
About this study
Official title: 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
The purpose of this study in healthy sexually active females is to evaluate the cycle control with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.
Read the 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.
- Conditions
- Contraception
- Being tested
- Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol
- Keywords
- contraception, bleeding, cycle control
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Cycle 1 to Cycle 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study director, Ortho-McNeil Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745901
- Sponsor's protocol ID
- CR015055
- Status last verified
- Dec 2012
- First submitted
- 2 Sep 2008
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 19935020
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00745901
- Acronym / sponsor ID
- CR015055
- Conditions
- Contraception
- Keywords
- contraception, bleeding, cycle control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Posted 25 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study in healthy sexually active females is to evaluate the cycle control with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol | Drug | – |
Primary outcome
Number of Days of Unscheduled Blood Loss - Cycle 1
Time frame: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
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.
Number of Days of Unscheduled Blood Loss - Cycle 2
Time frame: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)
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.
Number of Days of Unscheduled Blood Loss - Cycle 3
Time frame: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)
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.
Overall Number of Days of Unscheduled Blood Loss
Time frame: Cycle 1 to Cycle 3 (Day 8 to Day 80)
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.
Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
Time frame: Cycle 1 to Cycle 3 (Day 8 to Day 80)
Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day.
Number of Days of Scheduled Blood Loss - Cycle 1
Time frame: Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)
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.
Number of Days of Scheduled Blood Loss - Cycle 2
Time frame: Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)
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.
Number of Days of Scheduled Blood Loss - Cycle 3
Time frame: Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)
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.
Overall Number of Days of Scheduled Blood Loss
Time frame: Cycle 1 to Cycle 3 (Day 8 to Day 84)
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.
Number of Days of Total Blood Loss - Cycle 1
Time frame: Cycle 1 (Day 8 to Day 28)
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.
Number of Days of Total Blood Loss - Cycle 2
Time frame: Cycle 2 (day 29 to Day 56)
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.
Number of Days of Total Blood Loss - Cycle 3
Time frame: Cycle 3 (Day 57 to Day 84)
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.
Overall Number of Days of Total Blood Loss
Time frame: Cycle 1 to 3 (Day 8 to Day 84)
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.
Number of Participants With Unscheduled Bleeding Cycle 1
Time frame: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
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.
Number of Participants With Unscheduled Bleeding Cycle 2
Time frame: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)
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.
Number of Participants With Unscheduled Bleeding Cycle 3
Time frame: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)
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.
Number of Participants With Breakthrough Bleeding/Spotting Cycle 1
Time frame: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.
Number of Participants With Breakthrough Bleeding/Spotting Cycle 2
Time frame: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)
Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.
Number of Participants With Breakthrough Bleeding/Spotting Cycle 3
Time frame: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)
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.
1 secondary outcome
Patient Satisfaction - Overall
Time frame: Cycle 1 to Cycle 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19935020Kaunitz 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.
- 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 FemalesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial study director
Ortho-McNeil Janssen Scientific Affairs, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol in people with Contraception, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days of Unscheduled Blood Loss - Cycle 1 (time frame: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00745901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.