| Primary | Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD) | Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists. Percent change from Baseline was calculated as (BMD at Month 12 - BMD at Baseline)/BMD at Baseline * 100%. | Per-protocol analysis set, including all participants who received at least 1 dose of study treatment (does not apply to Control group), had both Baseline and one post-baseline assessment via DXA, and who completed all procedures at all scheduled study visits including the 12-month DXA scans, and did not have any major protocol violations. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Month 12 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0002.26± 0.168
- OG0011.45± 0.171
- OG0022.50± 0.139
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates. | | | | | LS Mean Difference | -0.23 | | | 2-Sided | 95 | -0.67 | 0.20 | | | Difference = OC group minus the untreated control | Yes | Non-Inferiority or Equivalence | 91-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%. |
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| Secondary | Change From Baseline in Lumbar Spine Bone Mineral Density | Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists. | Per-protocol analysis set | Posted | | Least Squares Mean | Standard Error | g/cm^2 | | Baseline, Month 6 and Month 12 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
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| Secondary | Change From Baseline in Lumbar Spine Bone Mineral Content (BMC) | Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists. | Per-protocol analysis set | Posted | | Least Squares Mean | Standard Error | g | | Baseline, Month 6 and Month 12 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
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| Secondary | Change From Baseline in Proximal Femur Bone Mineral Density | Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists. | Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by "n". | Posted | | Least Squares Mean | Standard Error | g/cm^2 | | Baseline, Month 6 and Month 12 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
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| Secondary | Change From Baseline in Proximal Femur Bone Mineral Content (BMC) | Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists. | Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by "n". | Posted | | Least Squares Mean | Standard Error | g | | Baseline, Month 6 and Month 12 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
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| Secondary | Change From Baseline in Total Body Bone Mineral Density | Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists. | Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by "n". | Posted | | Least Squares Mean | Standard Error | g/cm^2 | | Baseline, Month 6 and Month 12 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
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| Secondary | Change From Baseline in Total Body Bone Mineral Content (BMC) | Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists. | Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by "n". | Posted | | Least Squares Mean | Standard Error | g | | Baseline, Month 6 and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
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| Secondary | Change From Baseline in Bone-specific Alkaline Phosphatase | | Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by "n". | Posted | | Mean | Standard Deviation | µg/L | | Baseline, Month 6 and Month 12 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
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| Secondary | Change From Baseline in Serum Deoxypyridinoline | | Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by "n". | Posted | | Mean | Standard Deviation | nmol/L | | Baseline, Month 6 and Month 12 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
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| Secondary | Change From Baseline in Serum Osteocalcin | | Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by "n". | Posted | | Mean | Standard Deviation | nmol/L | | Baseline, Month 6 and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
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| Secondary | Change From Baseline in Serum Procollagen 1 N-terminal Propeptide | | Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by "n". | Posted | | Mean | Standard Deviation | µg/L | | Baseline, Month 6 and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
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| Secondary | Change From Baseline in Serum Type I Collagen N-telopeptide | | Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by "n". | Posted | | Mean | Standard Deviation | nM bone collagen equivalents (BCE) | | Baseline, Month 6 and Month 12 | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC | Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). | | OG002 | Untreated Control | Participants received no oral contraceptives during the study. |
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| Secondary | Number of Participants With Adverse Events (AEs) | An adverse event was any untoward medical occurrence in a clinical investigation subject participating in the clinical study, and did not necessarily need to have a causal relationship with treatment or the clinical study. The relationship of each adverse event to study treatment or procedures, and the severity and seriousness of each adverse event was judged by the investigator, as described below. A severe AE is defined as incapacitating, with inability to perform usual activities. A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:
- fatal or life-threatening;
- required or prolonged inpatient hospitalization;
- resulted in persistent or significant disability/incapacity;
- congenital anomaly or birth defect;
- important medical event.
| The safety analysis set includes data from all randomly assigned participants who received at least 1 dose of study treatment and from all participants enrolled in the control group who had baseline BMD measures via DXA. One participant randomly assigned to 91-day LNG received 21-day LNG instead and is included in the 21-day LNG group for safety. | Posted | | Number | | participants | | 12 months | | | | ID | Title | Description |
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| OG000 | 91-day Levonorgestrel OC | Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). | | OG001 | 28-day Levonorgestrel OC |
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