ContraceptionPhase 4NCT00204451
Human Ovarian Follicular Dynamics and Emergency Contraception
A Phase 4 study testing 0.75 levonorgestrel and 50 mg ethinyl estradiol/0.5 mg levonorgestrel in people with Contraception, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The researchers hypothesize that emergency contraception (EC) will initiate the changes associated with atresia or ovulatory failure at all stages of follicular development and that the image attributes associated with atresia will be similar regardless of the diameter of the dominant follicle when ovarian suppression… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- 0.75 levonorgestrel and 50 mg ethinyl estradiol/0.5 mg levonorgestrel
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2005to Jun 2006
- Phase
- Phase 4
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female volunteers of childbearing potential;
- Are first time users of oral contraception (OC) or have discontinued OC at least 1 month prior to study entry;
- Age between 18 and 40 years old;
- Normal body mass index (18-38);
- Has signed informed consent form; and
- Is in good health as confirmed by medical history, physical examination.
Who cannot join
- A positive pregnancy test will automatically exclude the volunteer from participation in this study.
- Any contraindication for oral contraception use;
- Irregular menstrual cycles;
- Ultrasonographic evidence of ovarian dysfunction, such as polycystic ovary syndrome (PCOS);
- Pregnancy (suspected or diagnosed) or lactation;
- History or suspicion of drug or alcohol abuse;
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- Participation in an investigational drug trial within the 30 days prior to selection;
- Exhibits a disorder that is a contraindication to steroid hormonal therapy, including, for example, the following conditions:
- history of, or actual, thrombophlebitis or thromboembolic disorders.
- history of, or actual, cerebrovascular disorders.
- history of, or actual, myocardial infarction or coronary artery disease.
- acute liver disease.
- history of, or actual, benign or malignant liver tumors.
- history of, or suspected, carcinoma of the breast.
- known, or suspected, estrogen-dependent neoplasia.
- undiagnosed abnormal vaginal bleeding.
- any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual field.
Trial locations and contacts
1 site in 1 country.
About this study
The researchers hypothesize that emergency contraception (EC) will initiate the changes associated with atresia or ovulatory failure at all stages of follicular development and that the image attributes associated with atresia will be similar regardless of the diameter of the dominant follicle when ovarian suppression is initiated. Second, changes associated with atresia may be observed, but ovulation of the dominant follicle is unimpeded.
Read the detailed description
This study is a single-center, randomized, open-label, double-controlled protocol to study the pattern of ovarian follicular growth and regression in two groups of women. The first group will use Plan B, which is a progesterone only OC containing 0.75 levonorgestrel. The second group of women will use the Yuzpe regimen, which uses 50 mg ethinyl estradiol/0.5 mg levonorgestrel pills at different stages of the menstrual follicular cycle.
- Conditions
- Contraception
- Being tested
- 0.75 levonorgestrel, 50 mg ethinyl estradiol/0.5 mg levonorgestrel
- Keywords
- emergency contraception, follicle, ovulation, blood pressure, Fertility Control, Inhibition of fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.75 levonorgestrelDrug
50 mg ethinyl estradiol/0.5 mg levonorgestrelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
follicle development
ovulation status
peripheral blood pressure
Secondary outcomes (1)
endometrial development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Roger Pierson, University of Saskatchewan
- Investigators
- Roger A Pierson, MS PhD, Principal investigator, University of SaskatchewanSalma T Hanna, MD PhD, Study director, University of SaskatchewanOlufemi A Olatunbosun, MD, Study chair, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204451
- Sponsor's protocol ID
- Bio 05-67
- Other IDs
- CIHR MOP 11489
- Status last verified
- Nov 2016
- First submitted
- 12 Sep 2005
- Last updated
- 28 Nov 2016
- Results posted
- No
Publications
Pierson RA, Archer DF, Moreau M, Shangold GA, Fisher AC, Creasy GW. Ortho Evra/Evra versus oral contraceptives: follicular development and ovulation in normal cycles and after an intentional dosing error. Fertil Steril. 2003 Jul;80(1):34-42. doi: 10.1016/s0015-0282(03)00556-9.
PubMed 12849799Baerwald AR, Adams GP, Pierson RA. A new model for ovarian follicular development during the human menstrual cycle. Fertil Steril. 2003 Jul;80(1):116-22. doi: 10.1016/s0015-0282(03)00544-2.
PubMed 12849812
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Ovarian Follicular Dynamics and Emergency Contraception
- ClinicalTrials.gov ID
- NCT00204451
- Acronym / sponsor ID
- Bio 05-67
- Conditions
- Contraception
- Keywords
- emergency contraception, follicle, ovulation, blood pressure, Fertility Control, Inhibition of fertilization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2005
- Study completion
- Jun 2006
- First posted
- 20 Sep 2005 (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 researchers hypothesize that emergency contraception (EC) will initiate the changes associated with atresia or ovulatory failure at all stages of follicular development and that the image attributes associated with atresia will be similar regardless of the diameter of the dominant follicle when ovarian suppression is initiated. Second, changes associated with atresia may be observed, but ovulation of the dominant follicle is unimpeded.
Detailed description
This study is a single-center, randomized, open-label, double-controlled protocol to study the pattern of ovarian follicular growth and regression in two groups of women. The first group will use Plan B, which is a progesterone only OC containing 0.75 levonorgestrel. The second group of women will use the Yuzpe regimen, which uses 50 mg ethinyl estradiol/0.5 mg levonorgestrel pills at different stages of the menstrual follicular cycle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female volunteers of childbearing potential;
- Are first time users of oral contraception (OC) or have discontinued OC at least 1 month prior to study entry;
- Age between 18 and 40 years old;
- Normal body mass index (18-38);
- Has signed informed consent form; and
Key exclusion criteria (17 listed)
- A positive pregnancy test will automatically exclude the volunteer from participation in this study.
- Any contraindication for oral contraception use;
- Irregular menstrual cycles;
- Ultrasonographic evidence of ovarian dysfunction, such as polycystic ovary syndrome (PCOS);
- Pregnancy (suspected or diagnosed) or lactation;
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 |
|---|---|---|
| 0.75 levonorgestrel | Drug | – |
| 50 mg ethinyl estradiol/0.5 mg levonorgestrel | Drug | – |
Primary outcome
follicle development
ovulation status
peripheral blood pressure
1 secondary outcome
endometrial development
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Background: PubMed 12849799Pierson RA, Archer DF, Moreau M, Shangold GA, Fisher AC, Creasy GW. Ortho Evra/Evra versus oral contraceptives: follicular development and ovulation in normal cycles and after an intentional dosing error. Fertil Steril. 2003 Jul;80(1):34-42. doi: 10.1016/s0015-0282(03)00556-9.
- Background: PubMed 12849812Baerwald AR, Adams GP, Pierson RA. A new model for ovarian follicular development during the human menstrual cycle. Fertil Steril. 2003 Jul;80(1):116-22. doi: 10.1016/s0015-0282(03)00544-2.
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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.
Roger A Pierson, MS PhD principal investigator
University of Saskatchewan
Salma T Hanna, MD PhD study director
University of Saskatchewan
Olufemi A Olatunbosun, MD study chair
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.75 levonorgestrel and 50 mg ethinyl estradiol/0.5 mg levonorgestrel in people with Contraception, run by University of Saskatchewan 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 6 inclusion and 17 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 28 Nov 2016. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
follicle development. The study lists 3 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 NCT00204451, which also lists 2 linked publications.
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 28 Nov 2016.