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.

Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.

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.

Safety population (received at least 1 dose of DR-102)

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.

Subset of participants with sufficient tissue at both Baseline and Endpoint biopsies.

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.

Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.

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.

Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used.

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.

Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used, and who were deemed to be compliant, per protocol.

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.

Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other BCMs, including condoms, were used, and who were deemed to be compliant, per protocol.

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.

Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in the body weight decile group.

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.

Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in body weight decile group.

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.

Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in body weight decile group.

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.

Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in BMI decile group.

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.

Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in BMI decile group.

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.

Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle and in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in BMI decile group.