NCT00775190

Brief 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. 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

April 17, 2017

Completed
Last Updated

April 17, 2017

Status Verified

March 1, 2017

Enrollment Period

5 years

First QC Date

October 17, 2008

Results QC Date

March 3, 2017

Last Update Submit

March 3, 2017

Conditions

Contraception

Keywords

birth control pillsoral contraceptivesbrand namegenericside effectsoral contraceptive side effectsdysfunctional uterine bleedingpre-menstrual symptoms

Outcome Measures

Primary Outcomes (3)

  • Amount of Bleeding

    Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).

    6 Months

  • Incidence of Breakthrough Bleeding

    Any breakthrough bleeding during reporting period.

    6 months

  • Days of Bleeding

    Number of days with bleeding during each menstrual period.

    6 months

Secondary Outcomes (6)

  • Side Effects (Nausea)

    6 months

  • Side Effects (Vomiting)

    6 Months

  • Side Effects (Breast Tenderness)

    6 Months

  • Side Effects (Mood Changes)

    6 months

  • Side Effects (Menstrual Cramps)

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Ortho tricyclen™

ACTIVE COMPARATOR

Participant Randomized to Ortho tricyclen 1 tablet by mouth Daily

Drug: ortho tricyclen

Trinessa™

ACTIVE COMPARATOR

Participant Randomized to Trinessa 1 tablet by mouth Daily

Drug: Trinessa

Interventions

ortho tricyclenDRUG

brand name oral contraceptive

Ortho tricyclen™
TrinessaDRUG

generic oral contraceptive

Trinessa™

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • pregnant
  • under the age of 18
  • over the age of 35
  • history of irregular uterine bleeding
  • history of ovarian cysts
  • history of fibroids
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Metrorrhagia

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

Early Study termination. No data analysis.

Results Point of Contact

Title
Evie Russell, RN
Organization
Beaumont Health System
Evie.Russell@beaumont.org
248-898-5388

Study Officials

  • Frances Bechek, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 20, 2008

Study Start

October 1, 2008

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

April 17, 2017

Results First Posted

April 17, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)