Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128726
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2005-08-08
Brief Title:
The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 217 regimen In addition the investigators hypothesize that there will be increased endometrial and ovarian suppression in the CCOCP regimen
Detailed Description:
In the US 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 ie 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 womans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD043332 | NIH | None | httpsreporternihgovquickSearchR01HD043332 |