ContraceptionNCT00775190
Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
A study testing ortho tricyclen and Trinessa in people with Contraception, run by Corewell Health East at 1 site in United States.
Trial summary
This is a randomized control trial of Ortho tricyclen versus Trinessa (generic equivalent) to determine if they have similar effects. Women will be randomized to receive either Ortho tricyclen or Trinessa oral contraceptives and will be asked to keep a daily dairy of any symptoms or bleeding experienced. 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
- Contraception
- What is being tested?
- ortho tricyclen and Trinessa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Nov 2013
- 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
- nonsmoker
- not pregnant
- not planning to become pregnant in the next 6 months
- not taking hormonal birth control for at least 3 months previous to entering the study
- no history of fibroids
- no history of ovarian cysts
- no history of dysfunctional uterine bleeding
Who cannot join
- pregnant
- under the age of 18
- over the age of 35
- history of irregular uterine bleeding
- history of ovarian cysts
- history of fibroids
Show all 11Show fewer
- history of migraines with aura
- history of liver disease
- family or personal history of Blood clots (thromboembolism)
- mental disabilities
- desire to become pregnant in the next six months
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
This is a randomized control trial of Ortho tricyclen versus Trinessa (generic equivalent) to determine if they have similar effects. Women will be randomized to receive either Ortho tricyclen or Trinessa oral contraceptives and will be asked to keep a daily dairy of any symptoms or bleeding experienced. Once a month, participants will be asked to complete a survey.
The objective is to compare generic oral contraceptives (OCPs) and brand name OCPs with respect to side effect profiles including bleeding patterns, mood changes, nausea and vomiting, frequency of menstrual cramps, breast tenderness, elevation in blood pressure, stroke, blood clots and patient compliance.
Read the detailed description
This is a double blind randomized controlled trial of Ortho tricyclen™ vs. Trinessa™ (generic equivalent) to determine if they have similar effects on bleeding patterns, namely days of menstrual flow, amount of bleeding, and intermenstrual bleeding. Women will score these parameters using a survey with objective measures for days of bleeding, amount of flow, and days of breakthrough bleeding. As secondary outcomes, we will compare the side effect profiles of each in regards to nausea, vomiting, breast tenderness, menstrual cramps, mood changes, and thromboembolic events.
Patients will record in their daily diary if one of the outcomes occurs or not. We will observe whether the events occur and the number of occurrences within the six month time period.
- Conditions
- Contraception
- Being tested
- ortho tricyclen, Trinessa
- Keywords
- birth control pills, oral contraceptives, brand name, generic, side effects, oral contraceptive side effects, dysfunctional uterine bleeding, pre-menstrual symptoms
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ortho tricyclenDrug
brand name oral contraceptive
TrinessaDrug
generic oral contraceptive
| Study group | Role | What they receive |
|---|---|---|
| Ortho tricyclen™ | Active comparator | Participant Randomized to Ortho tricyclen 1 tablet by mouth Daily Receives: Drug: ortho tricyclen |
| Trinessa™ | Active comparator | Participant Randomized to Trinessa 1 tablet by mouth Daily Receives: Drug: Trinessa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Bleeding
Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).
Measured: 6 Months
Incidence of Breakthrough Bleeding
Any breakthrough bleeding during reporting period.
Measured: 6 months
Days of Bleeding
Number of days with bleeding during each menstrual period.
Measured: 6 months
Secondary outcomes (6)
Side Effects (Nausea)
Number of days of nausea
Measured: 6 months
Side Effects (Vomiting)
Number of episodes of vomitting
Measured: 6 Months
Side Effects (Breast Tenderness)
Incidence of breast tenderness during the study time frame
Measured: 6 Months
Side Effects (Mood Changes)
Self reported changes in mood during each month over the time frame.
Measured: 6 months
Side Effects (Menstrual Cramps)
Intensity of menstrual cramps reported on a 4 point Likert scale.
Measured: 6 months
Side Effects (Incidence of Thromboembolic Events)
Occurrence of any thromboembolic events during the study time frame.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2013
- Study completionNov 2013
Why it stopped: unale to recruit , progress report not filed by PI
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 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Uckele, Corewell Health East
- Investigators
- Frances Bechek, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775190
- Sponsor's protocol ID
- 2008-184
- Status last verified
- Mar 2017
- First submitted
- 17 Oct 2008
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives
- ClinicalTrials.gov ID
- NCT00775190
- Acronym / sponsor ID
- 2008-184
- Conditions
- Contraception
- Keywords
- birth control pills, oral contraceptives, brand name, generic, side effects, oral contraceptive side effects, dysfunctional uterine bleeding, pre-menstrual symptoms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unale to recruit , progress report not filed by PI
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Posted 17 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized control trial of Ortho tricyclen versus Trinessa (generic equivalent) to determine if they have similar effects. Women will be randomized to receive either Ortho tricyclen or Trinessa oral contraceptives and will be asked to keep a daily dairy of any symptoms or bleeding experienced. Once a month, participants will be asked to complete a survey.
The objective is to compare generic oral contraceptives (OCPs) and brand name OCPs with respect to side effect profiles including bleeding patterns, mood changes, nausea and vomiting, frequency of menstrual cramps, breast tenderness, elevation in blood pressure, stroke, blood clots and patient compliance.
Detailed description
This is a double blind randomized controlled trial of Ortho tricyclen™ vs. Trinessa™ (generic equivalent) to determine if they have similar effects on bleeding patterns, namely days of menstrual flow, amount of bleeding, and intermenstrual bleeding. Women will score these parameters using a survey with objective measures for days of bleeding, amount of flow, and days of breakthrough bleeding. As secondary outcomes, we will compare the side effect profiles of each in regards to nausea, vomiting, breast tenderness, menstrual cramps, mood changes, and thromboembolic events.
Patients will record in their daily diary if one of the outcomes occurs or not. We will observe whether the events occur and the number of occurrences within the six month time period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ortho tricyclen™ | Active comparator | Drug: ortho tricyclenParticipant Randomized to Ortho tricyclen 1 tablet by mouth Daily |
| Trinessa™ | Active comparator | Drug: TrinessaParticipant Randomized to Trinessa 1 tablet by mouth Daily |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- nonsmoker
- not pregnant
- not planning to become pregnant in the next 6 months
- not taking hormonal birth control for at least 3 months previous to entering the study
- no history of fibroids
Key exclusion criteria (11 listed)
- pregnant
- under the age of 18
- over the age of 35
- history of irregular uterine bleeding
- history of ovarian cysts
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 |
|---|---|---|
| ortho tricyclenbrand name oral contraceptive | Drug | Ortho tricyclen™ |
| Trinessageneric oral contraceptive | Drug | Trinessa™ |
Primary outcome
Amount of Bleeding
Time frame: 6 Months
Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).
Incidence of Breakthrough Bleeding
Time frame: 6 months
Any breakthrough bleeding during reporting period.
Days of Bleeding
Time frame: 6 months
Number of days with bleeding during each menstrual period.
6 secondary outcomes
Side Effects (Nausea)
Time frame: 6 months
Side Effects (Vomiting)
Time frame: 6 Months
Side Effects (Breast Tenderness)
Time frame: 6 Months
Side Effects (Mood Changes)
Time frame: 6 months
Side Effects (Menstrual Cramps)
Time frame: 6 months
Side Effects (Incidence of Thromboembolic Events)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Frances Bechek, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ortho tricyclen and Trinessa in people with Contraception, run by Corewell Health East 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 11 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: stopped early, as of the sponsor's last update on 17 Apr 2017. 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 Apr 2017). 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?
Amount of Bleeding (time frame: 6 Months). 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?
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 Apr 2017.