ContraceptionPhase 3NCT00326404
Continuous Versus Cyclic Use of Oral Contraceptive Pills in Adolescents
A Phase 3 study testing Desogestrel-Ethinyl Estradiol 21 tablets and Desogestrel-Ethinyl Estradiol 28 tablets in people with Contraception, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The primary purpose of this study is to compare the compliance rates of adolescents who take oral contraceptives (OCPs) continuously to those who take OCPs cyclically. Read more about this study
- Who is it for?
- Ages 15 to 18 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Desogestrel-Ethinyl Estradiol 21 tablets and Desogestrel-Ethinyl Estradiol 28 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to May 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 15 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female
- Age 15 to 18
- Presenting to the Gynecology and Adolescent Medicine Clinic for contraception
Who cannot join
- Prior use of the study medication with no improvement in symptoms
- Any medical condition that indicates continuous OCPs (i.e. acute menorrhagia, dysmenorrhea that did not previously respond to cyclical OCP use)
- Personal history of or current thromboembolic disorder
- First-degree relative(s) with thromboembolic disorder
- Cerebrovascular disease
- Coronary artery disease
Show all 19Show fewer
- Cardiac valvular disease
- Hypertension (systolic blood pressure > 160 mmHg or diastolic > 100 mmHG)
- Diabetes with retinopathy/neuromyopathy/nephropathy)
- Breast cancer
- Endometrial cancer
- Undiagnosed abnormal uterine bleeding
- Cholestatic jaundice of pregnancy
- Hepatic tumor
- Known or suspected pregnancy
- Less than 6 months postpartum if breastfeeding
- Classic migraine with aura or any other neurological signs
- Gallbladder disease
- Taking any medications known to affect the efficacy of OCPs (i.e. phenytoin, phenobarbital, primidone, carbamazepine, griseofulvin, rifampin)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Lisa Allen, MD, 416 813 6188, lisa.allen@sickkids.ca
Lisa Allen, MD
About this study
Official title: Continuous Versus Cyclic Use of an Oral Contraceptive Pills in Adolescents
The primary purpose of this study is to compare the compliance rates of adolescents who take oral contraceptives (OCPs) continuously to those who take OCPs cyclically.
Read the detailed description
Oral contraceptive pills have traditionally been prescribed in a cyclical manner, where there are 21-24 days of active pills and 4-7 days of placebo pills or a pill-free interval, creating a 28-day cycle. It has now been proven that as long as a woman has both estrogen and progesterone, her uterine lining is protected and is thin. To that effect, a new OCP (Seasonale®, Barr Laboratories, Pomona, NY) has been packaged in the United States that combines 84 days of active pills with 7 days of placebo pills. This allows a withdrawal bleed every 3 months.
Like in adult women, OCPs are the most popular form of birth control and cycle control in adolescents. But, for a variety of reasons, adolescents tend to have poorer compliance when taking OCPs. Adult women tend to be noncompliant about 6% of the time, but, by the end of one year, adolescents have a non-compliance rate of 34-66%.
There have been few studies that even describe improved compliance and decreased ovarian follicular development in women who take OCPs continuously, which could be beneficial in decreasing the rate of adolescent pregnancy. The majority of the studies looking at continuous use of OCPs have been performed in adult women. At present, there has been only one article that has addressed the use of continuous OCPs in adolescents. Sucato and Gold discussed the indications of continuous use of OCPs, how to prescribe them, and what type of progestin to use; but they did not specifically examine compliance or the safety and efficacy of continuous OCPs in adolescents. We plan to evaluate these issues in our study.
- Conditions
- Contraception
- Being tested
- Desogestrel-Ethinyl Estradiol 21 tablets, Desogestrel-Ethinyl Estradiol 28 tablets
- Keywords
- Oral Contraceptives, Adolescents, Compliance
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desogestrel-Ethinyl Estradiol 21 tabletsDrug
Also called Marvelon-21
The participants in the continuous study arm will be given 4 packs of Marvelon-21, so that they can take the pills continuously for 84 days followed by no medication for 7 days. During these 7 days, the participant will have a withdrawal bleed. This sequence is repeated by the participant for a total of 12 months. Each patient in the continuous arm will have 4 withdrawal bleeds per year.
Desogestrel-Ethinyl Estradiol 28 tabletsDrug
Also called Marvelon-28
The participants in the cyclical arm of the study will be given 3 packs of Marvelon-28 and asked to take all the pills in the packet, including the placebo pills. During the week of placebo pills, these participants will have a withdrawal bleed. Each patient in the cyclical arm will have 12 withdrawal bleeds per year. The duration of study drug treatment for both arms is 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Desogestrel-Ethinyl Estradiol 21 tablets |
| 2 | Active comparator | Not described Receives: Drug: Desogestrel-Ethinyl Estradiol 28 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to compare the compliance rates of adolescents who take OCPs continuously to those who take OCPs cyclically.
Measured: 1 year
Secondary outcomes (1)
The number of girls who have positive pregnancy test results at 12 months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2008 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Lisa Allen, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326404
- Sponsor's protocol ID
- 1000008437
- Status last verified
- Jul 2008
- First submitted
- 12 May 2006
- Last updated
- 18 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Walpole B, Dettmer E, Morrongiello B, McCrindle B, Hamilton J. Motivational interviewing as an intervention to increase adolescent self-efficacy and promote weight loss: methodology and design. BMC Public Health. 2011 Jun 10;11:459. doi: 10.1186/1471-2458-11-459.
PubMed 21663597
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Cyclic Use of an Oral Contraceptive Pills in Adolescents
- ClinicalTrials.gov ID
- NCT00326404
- Acronym / sponsor ID
- 1000008437
- Conditions
- Contraception
- Keywords
- Oral Contraceptives, Adolescents, Compliance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- May 2006
- Primary completion
- May 2008 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 16 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to compare the compliance rates of adolescents who take oral contraceptives (OCPs) continuously to those who take OCPs cyclically.
Detailed description
Oral contraceptive pills have traditionally been prescribed in a cyclical manner, where there are 21-24 days of active pills and 4-7 days of placebo pills or a pill-free interval, creating a 28-day cycle. It has now been proven that as long as a woman has both estrogen and progesterone, her uterine lining is protected and is thin. To that effect, a new OCP (Seasonale®, Barr Laboratories, Pomona, NY) has been packaged in the United States that combines 84 days of active pills with 7 days of placebo pills. This allows a withdrawal bleed every 3 months.
Like in adult women, OCPs are the most popular form of birth control and cycle control in adolescents. But, for a variety of reasons, adolescents tend to have poorer compliance when taking OCPs. Adult women tend to be noncompliant about 6% of the time, but, by the end of one year, adolescents have a non-compliance rate of 34-66%.
There have been few studies that even describe improved compliance and decreased ovarian follicular development in women who take OCPs continuously, which could be beneficial in decreasing the rate of adolescent pregnancy. The majority of the studies looking at continuous use of OCPs have been performed in adult women. At present, there has been only one article that has addressed the use of continuous OCPs in adolescents. Sucato and Gold discussed the indications of continuous use of OCPs, how to prescribe them, and what type of progestin to use; but they did not specifically examine compliance or the safety and efficacy of continuous OCPs in adolescents. We plan to evaluate these issues in our study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Desogestrel-Ethinyl Estradiol 21 tablets |
| 2 | Active comparator | Drug: Desogestrel-Ethinyl Estradiol 28 tablets |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Female
- Age 15 to 18
- Presenting to the Gynecology and Adolescent Medicine Clinic for contraception
Key exclusion criteria (19 listed)
- Prior use of the study medication with no improvement in symptoms
- Any medical condition that indicates continuous OCPs (i.e. acute menorrhagia, dysmenorrhea that did not previously respond to cyclical OCP use)
- Personal history of or current thromboembolic disorder
- First-degree relative(s) with thromboembolic disorder
- Cerebrovascular disease
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 |
|---|---|---|
| Desogestrel-Ethinyl Estradiol 21 tabletsAlso: Marvelon-21The participants in the continuous study arm will be given 4 packs of Marvelon-21, so that they can take the pills continuously for 84 days followed by no medication for 7 days. During these 7 days, the participant will have a withdrawal bleed. This sequence is repeated by the participant for a total of 12 months. Each patient in the continuous arm will have 4 withdrawal bleeds per year. | Drug | 1 |
| Desogestrel-Ethinyl Estradiol 28 tabletsAlso: Marvelon-28The participants in the cyclical arm of the study will be given 3 packs of Marvelon-28 and asked to take all the pills in the packet, including the placebo pills. During the week of placebo pills, these participants will have a withdrawal bleed. Each patient in the cyclical arm will have 12 withdrawal bleeds per year. The duration of study drug treatment for both arms is 12 months. | Drug | 2 |
Primary outcome
The primary objective is to compare the compliance rates of adolescents who take OCPs continuously to those who take OCPs cyclically.
Time frame: 1 year
1 secondary outcome
The number of girls who have positive pregnancy test results at 12 months
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2008.
- Derived from this study: PubMed 21663597Walpole B, Dettmer E, Morrongiello B, McCrindle B, Hamilton J. Motivational interviewing as an intervention to increase adolescent self-efficacy and promote weight loss: methodology and design. BMC Public Health. 2011 Jun 10;11:459. doi: 10.1186/1471-2458-11-459.
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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.
Lisa Allen, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desogestrel-Ethinyl Estradiol 21 tablets and Desogestrel-Ethinyl Estradiol 28 tablets in people with Contraception, run by The Hospital for Sick Children at 1 site in Canada.
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 3 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 18 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Allen, MD (416-813-6188, lisa.allen@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to compare the compliance rates of adolescents who take OCPs continuously to those who take OCPs cyclically. (time frame: 1 year). 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 NCT00326404, 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 18 Jul 2008.