Menstrual CycleNCT00128726
The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function
An observational study of Menstrual Cycle and Healthy, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of a continuous combined oral contraceptive pill (CCOCP) regimen. The investigators hypothesize that there will be a decrease in the number of vaginal bleeding days in the continuous regimen compared to a traditional 21/7 regimen. 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
- Menstrual Cycle, Healthy
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Aug 2006
- Phase
- Observational
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women between 18-35 years of age who wish to use a continuous combined oral contraceptive and are non-smokers. Must have regular menstrual cycles for a 3 month period.
Who may be able to join
- Healthy women of legal age of consent between 18-35 years who wish to use a continuous combined oral contraceptive and are non-smokers.
- Must have a regular (25-31) day menstrual cycle for the three month period preceding enrollment.
- Subject will comply with protocol, in the opinion of the investigator.
Who cannot join
- Thrombophlebitis
- Known or suspected clotting disorders
- Cerebrovascular or coronary artery disease or myocardial infarction
- Malignancy
- Known or suspected estrogen dependent neoplasia
- Undiagnosed abnormal genital bleeding
Show all 31Show fewer
- Benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products
- Hyperlipidemia - fasting cholesterol level greater than 6.73 mmol/L (260mg); fasting triglyceride level greater than 3.39 mmol/L (300mg/dl); high cholesterol.
- Diabetes mellitus
- Migraine or increased sensitivity of headaches during previous estrogen or oral contraceptive study
- Depression requiring hospitalization or associated with suicidal ideation
- Chronic renal disease
- Known hypersensitivity to estrogens and/or progestogens
- Neuro-ocular disorders
- Cholestatic jaundice
- Pregnancy while taking oral contraceptives
- Persistent non compliance with taking medication
- Serious adverse experiences with oral contraceptive use
- Malabsorption due to illness or surgery
- Use of any experimental drug or device within the last 90 days before study drug administration
- Any anticonvulsant medications
- Any use of rifampin within 3 months of enrollment
- Any use of lipid lowering agents
- Impaired liver function or disease
- Known or suspected pregnancy
- Hypertension whether treated or untreated
- Cervical cytological smear or low grade squamous intraepithelial lesion (SIL) or greater that is untreated within the last year
- The use of an intrauterine device (IUD) or injectable or implantable estrogen, progestogens, or androgens during the six month period before enrollment; or oral contraceptive or sex hormone use within three cycles before enrollment.
- Breast feeding
- Known or suspected alcoholism or drug abuse
- Smoking
Trial locations and contacts
1 site in 1 country.
United States1 site
The Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
About this study
The purpose of this study is to determine the safety and efficacy of a continuous combined oral contraceptive pill (CCOCP) regimen. The investigators hypothesize that there will be a decrease in the number of vaginal bleeding days in the continuous regimen compared to a traditional 21/7 regimen. In addition, the investigators hypothesize that there will be increased endometrial and ovarian suppression in the CCOCP regimen.
Read the detailed description
In the U.S. many women of reproductive age use some form of contraception, 23% of whom use estrogen-progesterone combined oral contraceptives. Low-dose oral contraceptives suppress ovulation and dominant follicle selection by inhibiting luteinizing hormone and follicle stimulating hormone secretion by the pituitary gland. Under social, cultural and religious influences, women have traditionally been prescribed oral contraceptives in a pattern of 21 days of active pills with seven days of inactive pills as a way of mimicking the natural menstrual cycle and provide reassurance of the absence of pregnancy by a withdrawal bleed during the placebo period. However, the withdrawal bleeding that occurs during the placebo period may still present with debilitating menstrual symptoms such as cramping, spotting break through bleeding, menstrual migraines and anemia. These menstrual disorders remain one of the most common reasons for prescribing the oral contraceptives. Suppression of bleeding by discarding the seven placebo tablets has been advocated for women with severe mental disabilities that impair hygiene and proper use, as well as for occasional use by women inconvenienced by menstruation (i.e. female athletes during competition and women in the military). Additionally, many physicians have used oral contraceptive pill regimens to treat endometriosis, premenstrual syndrome, anovulatory dysfunctional uterine bleeding, acne, hirsutism and anemia. The seven day pills free ovarian axis and ovarian follicular development and increase ovarian sex steroid production which may result in mild exacerbations of the treated condition. There is a growing patient preference to avoid vaginal bleeding completely, both in pre-menopausal and post-menopausal hormone replacement regimens in the general population. This is reflected in a woman's attitude about changing menstrual bleeding patterns as assessed by a 1996 Dutch survey. The majority of women in all studied age groups said that they would prefer decreasing the frequency of bleeding to less than once a month or completely eliminating menses altogether through the use of oral contraceptives. Therefore, reducing bleeding days is an important goal for improving quality of life in women suffering from the discomfort and inconvenience of withdrawal bleeding.
- Conditions
- Menstrual Cycle, Healthy
- Keywords
- continuous combined oral contraceptive, endometrial and ovarian suppression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startJun 2001
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard S. Legro, M.D., Milton S. Hershey Medical Center
- Investigators
- Richard S Legro, M.D., Principal investigator, The Penn State Hershey Medical Center/College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128726
- Sponsor's protocol ID
- HY01-190
- Other IDs
- R01HD043332
- Status last verified
- Dec 2012
- First submitted
- 8 Aug 2005
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function
- ClinicalTrials.gov ID
- NCT00128726
- Acronym / sponsor ID
- HY01-190
- Conditions
- Menstrual Cycle, Healthy
- Keywords
- continuous combined oral contraceptive, endometrial and ovarian suppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jun 2001
- Study completion
- Aug 2006 (actual)
- First posted
- 10 Aug 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 purpose of this study is to determine the safety and efficacy of a continuous combined oral contraceptive pill (CCOCP) regimen. The investigators hypothesize that there will be a decrease in the number of vaginal bleeding days in the continuous regimen compared to a traditional 21/7 regimen. In addition, the investigators hypothesize that there will be increased endometrial and ovarian suppression in the CCOCP regimen.
Detailed description
In the U.S. many women of reproductive age use some form of contraception, 23% of whom use estrogen-progesterone combined oral contraceptives. Low-dose oral contraceptives suppress ovulation and dominant follicle selection by inhibiting luteinizing hormone and follicle stimulating hormone secretion by the pituitary gland. Under social, cultural and religious influences, women have traditionally been prescribed oral contraceptives in a pattern of 21 days of active pills with seven days of inactive pills as a way of mimicking the natural menstrual cycle and provide reassurance of the absence of pregnancy by a withdrawal bleed during the placebo period. However, the withdrawal bleeding that occurs during the placebo period may still present with debilitating menstrual symptoms such as cramping, spotting break through bleeding, menstrual migraines and anemia. These menstrual disorders remain one of the most common reasons for prescribing the oral contraceptives. Suppression of bleeding by discarding the seven placebo tablets has been advocated for women with severe mental disabilities that impair hygiene and proper use, as well as for occasional use by women inconvenienced by menstruation (i.e. female athletes during competition and women in the military). Additionally, many physicians have used oral contraceptive pill regimens to treat endometriosis, premenstrual syndrome, anovulatory dysfunctional uterine bleeding, acne, hirsutism and anemia. The seven day pills free ovarian axis and ovarian follicular development and increase ovarian sex steroid production which may result in mild exacerbations of the treated condition. There is a growing patient preference to avoid vaginal bleeding completely, both in pre-menopausal and post-menopausal hormone replacement regimens in the general population. This is reflected in a woman's attitude about changing menstrual bleeding patterns as assessed by a 1996 Dutch survey. The majority of women in all studied age groups said that they would prefer decreasing the frequency of bleeding to less than once a month or completely eliminating menses altogether through the use of oral contraceptives. Therefore, reducing bleeding days is an important goal for improving quality of life in women suffering from the discomfort and inconvenience of withdrawal bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women between 18-35 years of age who wish to use a continuous combined oral contraceptive and are non-smokers. Must have regular menstrual cycles for a 3 month period.
Key inclusion criteria (3 listed)
- Healthy women of legal age of consent between 18-35 years who wish to use a continuous combined oral contraceptive and are non-smokers.
- Must have a regular (25-31) day menstrual cycle for the three month period preceding enrollment.
- Subject will comply with protocol, in the opinion of the investigator.
Key exclusion criteria (31 listed)
- Thrombophlebitis
- Known or suspected clotting disorders
- Cerebrovascular or coronary artery disease or myocardial infarction
- Malignancy
- Known or suspected estrogen dependent neoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 21 Dec 2012.
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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.
Richard S Legro, M.D. principal investigator
The Penn State Hershey Medical Center/College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle and Healthy, run by Milton S. Hershey Medical Center 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 3 inclusion and 31 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 21 Dec 2012. 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?
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.
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 21 Dec 2012; AzTrials last refreshed its copy on 8 Nov 2026.