Oral ContraceptiveOCP2NCT01318005

Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation

A study testing Oral Contraceptive: Ortho-Novum® 1/35, Oral Contraceptive: Ovcon® 35 and Oral Contraceptive: Microgestin Fe® 1/20 in people with Oral Contraceptive, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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 estrogen (a hormone in the birth control pill) may have… Read more about this study

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Oral Contraceptive
What is being tested?: Oral Contraceptive: Ortho-Novum® 1/35, Oral Contraceptive: Ovcon® 35 and Oral Contraceptive: Microgestin Fe® 1/20
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteUnited States
Study dates: 14 Feb 2011to 30 Jun 2015
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 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Age 18-35
BMI <30 kg/m2
Premenopausal with regular cycles or currently taking an OC
Not currently or recently pregnant or nursing (within previous 6 months)
Non-smoker
No use of antibiotics within the prior 4 weeks

Show all 10Show fewer

Competent to provide written informed consent (as judged by study team)
Willing to adhere to the OC regimen
Willingness to refrain from the use of aspirin or NSAIDS 10 days pior to the biopsy appointment and one week following the biopsy procedure
Willing and able to refrain from use of fish oils 10 days prior to the biopsy appointment and one week following the biopsy procedure

Who cannot join

Diabetes
Abnormal breast examination
Abnormal PT/INR and/or CBC with platelets test results (as determined by one of the study physicians)
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

Trial locations and contacts

1 site in 1 country.

United States1 site

USC University Hospital
Los Angeles, California, 90033

Other trials in United States

About this study

Official title: The Effects of Dose and Formulation of Oral Contraceptives (OCs) on Breast-Cell Proliferation: Can the Chemopreventive Effects of OCs on Endometrial and Ovarian Cancer be Extended to Breast Cancer?

Conditions: Oral Contraceptive
Being tested: Oral Contraceptive: Ortho-Novum® 1/35, Oral Contraceptive: Ovcon® 35, Oral Contraceptive: Microgestin Fe® 1/20

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: Ortho-Novum® 1/35, pill, 2-3 mos, daily.
Oral Contraceptive: Ovcon® 35Drug
Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.
Oral Contraceptive: Microgestin Fe® 1/20Drug
Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.

Study groups in NCT01318005
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® 35	Active comparator	Ovcon® 35 is an oral contraceptive that contains less progestin. Receives: Drug: Oral Contraceptive: Ovcon® 35
Microgestin Fe® 1/20	Active comparator	is an oral contraceptive that contains less estrogen. Receives: Drug: Oral Contraceptive: Microgestin Fe® 1/20

What is being measured

The primary outcome is the main question the study is designed to answer.

Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups
Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells
Measured: Up to 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 201130 Jun 2015

First posted18 Mar 2011 (estimated)
Study start14 Feb 2011
Primary completion30 Jun 2014
Study completion30 Jun 2015

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.
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: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01318005
Sponsor's protocol ID: HS-10-00455
Acronym: OCP2
Status last verified: Jan 2018
First submitted: 16 Mar 2011
Last updated: 17 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Postprandial Glucose Handing in Contraceptive and IUD Users
Glucose Homeostasis
Active, not recruitingPhase 1
A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity
Healthy Participants
RecruitingPhase 1
A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
Advanced Malignancies
RecruitingPhase 1
A Study of Eloralintide (LY3841136) in Female Participants With Obesity or Overweight
Obesity, Overweight
RecruitingPhase 1
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants
Healthy Volunteers

All Oral Contraceptive trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Dose and Formulation of Oral Contraceptives (OCs) on Breast-Cell Proliferation: Can the Chemopreventive Effects of OCs on Endometrial and Ovarian Cancer be Extended to Breast Cancer?
ClinicalTrials.gov ID: NCT01318005
Acronym / sponsor ID: OCP2 / HS-10-00455
Conditions: Oral Contraceptive
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: University of Southern CaliforniaUniversity, hospital or other
Study start: 14 Feb 2011 (actual)
Primary completion: 30 Jun 2014 (actual)
Study completion: 30 Jun 2015 (actual)
First posted: 18 Mar 2011 (estimated)
Results: Posted 17 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

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® 35	Active comparator	Drug: Oral Contraceptive: Ovcon® 35Ovcon® 35 is an oral contraceptive that contains less progestin.
Microgestin Fe® 1/20	Active comparator	Drug: Oral Contraceptive: Microgestin Fe® 1/20is an oral contraceptive that contains less estrogen.

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Age 18-35
BMI <30 kg/m2
Premenopausal with regular cycles or currently taking an OC
Not currently or recently pregnant or nursing (within previous 6 months)
Non-smoker

Key exclusion criteria (7 listed)

Diabetes
Abnormal breast examination
Abnormal PT/INR and/or CBC with platelets test results (as determined by one of the study physicians)
History or current therapeutic or prophylactic use of anticoagulants
Known bleeding disorder or history of unexplained bleeding or bruising

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® 1/35Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily.	Drug	Ortho-Novum® 1/35
Oral Contraceptive: Ovcon® 35Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.	Drug	Ovcon® 35
Oral Contraceptive: Microgestin Fe® 1/20Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.	Drug	Microgestin Fe® 1/20

Primary outcome

Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups
Time frame: Up to 3 months.
Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells

Results and safety

Results posted to the registry on 17 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ortho-Novum® 1/35	30	30
Ovcon® 35	26	26
Microgestin Fe® 1/20	26	26

Primary outcome: Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups

Time frame: Up to 3 months.. Mean (95% Confidence Interval). Unit: Percent of cells staining for Ki67

Measure	Ortho-Novum® 1/35 n = 25	Ovcon® 35 n = 19	Microgestin Fe® 1/20 n = 24
Value	8.5 (5.7 to 12.5)	11.9 (7.5 to 18.9)	7.5 (4.8 to 11.7)

Ortho-Novum® 1/35 vs Ovcon® 35 vs Microgestin Fe® 1/20: Simon Optimum two-stage: 11 (95% CI 7 to 18)

Population analysed: One participant was diagnosed with follicular cyst on the day of biopsy, 7 had insufficient specimen, 3 had low levels of corticosteroid binding globulin (CBG) and were dropped as being inconsistent users, while 3 had no CBG data available and were dropped for consistency, leaving 68 evaluable participants.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ortho-Novum® 1/35	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Ovcon® 35	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Microgestin Fe® 1/20	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Oral Contraceptive

RecruitingObservational study
Postprandial Glucose Handing in Contraceptive and IUD Users
Glucose Homeostasis
Active, not recruitingPhase 1
A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity
Healthy Participants
RecruitingPhase 1
A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
Advanced Malignancies
RecruitingPhase 1
A Study of Eloralintide (LY3841136) in Female Participants With Obesity or Overweight
Obesity, Overweight
RecruitingPhase 1
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants
Healthy Volunteers

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.

Heather MacDonald, 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?

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 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 17 Feb 2026. 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 17 Feb 2026). 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 Three Oral Contraceptive Groups (time frame: Up to 3 months.). 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 NCT01318005.

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 17 Feb 2026.