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The degree of suppression and subsequent activation of the hypothalamic-pituitary-ovarian axis during the hormone-free interval in combined oral contraceptive (COC) hormone users varies depending on the dose of ethinyl estradiol in the formulation. This variation in activation may be associated with different side effects during the hormone free interval. Progesterone (P) remained suppressed during all 6 COC regimens (<1.8 ng/mL), which indicates continuous contraceptive efficacy during the 7-day hormone free interval of all formulations studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy reproductive age women | These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combined oral contraceptives | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Follicle-stimulating Hormone | mean FSH on day 7 of the pill free interval | Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval. |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy, reproductive age women 18 to 35 years old, who were seeking contraception from the general gynecology clinics of the LAC and USC Medical Center were recruited. The research team identified potential candidates who were taking one of 6 possible monophasic COC formulations. Informed consent was obtained from participants by the research staff. To be eligible for participation, women reported regular menstrual cycles prior to COCs, and had taken at least 3 cycles of the same monophasic COC prior to enrollment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAC and USC Medical Center | Los Angeles | California | United States |
voluntary
clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Reproductive Age Women | These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months combined oral contraceptives |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Reproductive Age Women |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Follicle-stimulating Hormone | mean FSH on day 7 of the pill free interval | Of note 1 person from the 20 and another from the 30 mcg EE groups hand significant loss of sample and poor processing due to limitations with processing and transport. As a result of this not all participants were able to contribute data for analysis | Posted | Mean | Standard Deviation | milli international units per milliliter | Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Reproductive Age Women | These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months combined oral contraceptives |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Cho | University Reproductive Associates | (201) 288-6330 | michaelcho@nyc.com |
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| ID | Term |
|---|---|
| D003277 | Contraceptives, Oral, Combined |
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| C020416 | norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination |
| C014715 | Norinyl |
| ID | Term |
|---|---|
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003276 | Contraceptives, Oral |
| D003271 | Contraceptive Agents, Female |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months
| OG002 | 35 mcg EE | These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
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| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |