Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs |
AEs summarized are those that began or worsened after treatment with investigational product (IP). An AE is any untoward medical occurrence in a subject or clinical investigation subject participating in a clinical study and which does not necessarily have to have a causal relationship with this treatment or clinical study. Severity of AEs was assessed as mild, moderate or severe. A severe AE was defined as incapacitating, with inability to perform usual activity. An AE was defined as treatment-related when there is reasonable possibility that the AE was caused by or attributed to the IP and/or a causal relationship cannot be ruled out. An SAE was defined as one that meets any one of the following criteria: fatal or life-threatening; requires or prolongs in-patient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event. |
Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year. |
|
| Other |
Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint |
A subset of study participants agreed to have baseline and endpoint (Week 51/Early Withdrawal) endometrial biopsies. Results were provided for assessment of endometrial tissue/glands. Atrophic: scant or moderate amount of tissue, consists of tiny strips and wisps of surface endometrium or small tubular glands with scant or absent luminal secretions. Inactive: tubular glands lined by epithelial cells with mild pseudostratified and elongated nuclei. Proliferative: tubular or elongated glands lined by cells with elongated, dense, pseudostratified nuclei. Secretory: glands are tortuous or coiled with subnuclear vacuolation, secretion, and intraluminal tufts. Hyperplasia: proliferative type of glands showing glandular crowding with irregular shapes and sizes of enlargement, budding, and branching. Menstrual: glandular and stromal breakdown with fibrin thrombi in small vessels, condensed and collapsed stroma, and necrotic debris. |
Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal) |
|
| Primary |
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule |
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. |
thirteen 28-day cycles |
|
| Primary |
Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule |
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. |
thirteen 28-day cycles |
|
| Primary |
Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule |
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication. |
thirteen 28-day cycles |
|
| Secondary |
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight |
A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles. |
thirteen 28-day cycles |
|
| Secondary |
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight |
A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication. |
thirteen 28-day cycles |
|
| Secondary |
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule |
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. |
thirteen 28-day cycles |
|
| Secondary |
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule |
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. |
thirteen 28-day cycles |
|
| Secondary |
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule |
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication. |
thirteen 28-day cycles |
|
| Secondary |
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule |
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. |
thirteen 28-day cycles |
|
| Secondary |
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule |
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. |
thirteen 28-day cycles |
|
| Secondary |
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule |
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication. |
thirteen 28-day cycles |
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