Oral ContraceptiveNCT00972439
Oral Contraceptive (OC) Progestin Dose and Breast Proliferation
A study testing Oral Contraceptive: Ortho-Novum® 1/35 and Oral Contraceptive: Ovcon Fe® in people with Oral Contraceptive, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have… Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oral Contraceptive
- What is being tested?
- Oral Contraceptive: Ortho-Novum® 1/35 and Oral Contraceptive: Ovcon Fe®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Nov 2008
- Phase
- Interventional
- 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 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-34.
- Premenopausal.
- Currently taking or want to start oral contraceptives for contraception
- Non-smoker.
- Competent to give informed consent (as judged by the investigator).
- Provided written informed consent.
- Willingness to refrain from smoking and consumption of grapefruit or grapefruit juice during the study (grapefruit interferes with metabolism of exogenously administered OCs).
Who cannot join
- Abnormal breast examination.
- History or current therapeutic or prophylactic use of anticoagulants.
- Known bleeding disorder or history of unexplained bleeding or bruising.
- History of breast cancer or previous diagnostic breast biopsy.
- Known allergy to local anesthetic.
- Currently pregnant or pregnant within the previous 6 months.
- Having any standard contra-indication to being prescribed OCs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County Hospital
Los Angeles, California, 90033
About this study
Official title: Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation
The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.
- Conditions
- Oral Contraceptive
- Being tested
- Oral Contraceptive: Ortho-Novum® 1/35, Oral Contraceptive: Ovcon Fe®
- Keywords
- Oral Contraceptives, Breast Tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Contraceptive: Ortho-Novum® 1/35Drug
Oral Contraceptive: Ovcon Fe®Drug
| Study group | Role | What they receive |
|---|---|---|
| Ortho-Novum® 1/35 | Active comparator | Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. Receives: Drug: Oral Contraceptive: Ortho-Novum® 1/35 |
| Ovcon Fe® | Active comparator | Ovcon Fe® is an oral contraceptive that contains less progestin. Receives: Drug: Oral Contraceptive: Ovcon Fe® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups
Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startAug 2007
- Primary completionNov 2008
- Study completionNov 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 Oral ContraceptiveStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- DeShawn Taylor, M.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972439
- Sponsor's protocol ID
- HS-07-00269
- Status last verified
- Dec 2017
- First submitted
- 3 Sep 2009
- Last updated
- 23 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hovanessian-Larsen L, Taylor D, Hawes D, Spicer DV, Press MF, Wu AH, Pike MC, Pearce CL. Lowering oral contraceptive norethindrone dose increases estrogen and progesterone receptor levels with no reduction in proliferation of breast epithelium: a randomized trial. Contraception. 2012 Sep;86(3):238-43. doi: 10.1016/j.contraception.2011.12.015. Epub 2012 Feb 9.
PubMed 22325110
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation
- ClinicalTrials.gov ID
- NCT00972439
- Acronym / sponsor ID
- HS-07-00269
- Conditions
- Oral Contraceptive
- Keywords
- Oral Contraceptives, Breast Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Aug 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 Sep 2009 (estimated)
- Results
- Posted 23 Feb 2018
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 research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ortho-Novum® 1/35 | Active comparator | Drug: Oral Contraceptive: Ortho-Novum® 1/35Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. |
| Ovcon Fe® | Active comparator | Drug: Oral Contraceptive: Ovcon Fe®Ovcon Fe® is an oral contraceptive that contains less progestin. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-34.
- Premenopausal.
- Currently taking or want to start oral contraceptives for contraception
- Non-smoker.
- Competent to give informed consent (as judged by the investigator).
Key exclusion criteria (7 listed)
- Abnormal breast examination.
- History or current therapeutic or prophylactic use of anticoagulants.
- Known bleeding disorder or history of unexplained bleeding or bruising.
- History of breast cancer or previous diagnostic breast biopsy.
- Known allergy to local anesthetic.
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 |
|---|---|---|
| Oral Contraceptive: Ortho-Novum® 1/35 | Drug | Ortho-Novum® 1/35 |
| Oral Contraceptive: Ovcon Fe® | Drug | Ovcon Fe® |
Primary outcome
Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups
Time frame: 32 weeks
Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22325110Hovanessian-Larsen L, Taylor D, Hawes D, Spicer DV, Press MF, Wu AH, Pike MC, Pearce CL. Lowering oral contraceptive norethindrone dose increases estrogen and progesterone receptor levels with no reduction in proliferation of breast epithelium: a randomized trial. Contraception. 2012 Sep;86(3):238-43. doi: 10.1016/j.contraception.2011.12.015. Epub 2012 Feb 9.
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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.
DeShawn Taylor, M.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Contraceptive: Ortho-Novum® 1/35 and Oral Contraceptive: Ovcon Fe® in people with Oral Contraceptive, run by University of Southern California at 1 site in United States.
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 7 inclusion and 7 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 23 Feb 2018. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2018). 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?
Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups (time frame: 32 weeks). 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 NCT00972439, 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 23 Feb 2018.