Trial Outcomes & Findings for Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control (NCT NCT01250210)

Last Updated: 2018-07-05

Results Overview

Ovulation suppression measured by possible ovulation. Possible ovulation is defined as cycles with greatest progesterone level ≥4.7 ng/mL across Cycles 1-3 combined for each Arm/Group. The following four primary analysis datasets are: Intent-to-treat (ITT): At least 1 study patch was applied and at least 1 progesterone measurement is available at 1 of the nominal data collection points. Complete progesterone: At least 1 study patch was applied and at least 3 progesterone measurements are available across any of the data collection points. Perfect compliance: If no patch has been off \>1 day and no more than 1 day has elapsed between patch changes. Verifiable compliance: is a cycle during which at least 1 study patch was applied and where LNG and EE measurements were available at each of the nominal data collection points of Days 8, 15, and 22, and all values were above the lower detection limit.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

123 participants

Primary outcome timeframe

3 months

Results posted on

2018-07-05

Participant Flow

Planned enrollment included: approximately 30 subjects in the AG200LE treatment group, 30 subjects in the AG200 treatment group and 20 to 30 subjects in the AG200 15 treatment group. Actual enrollment included: 45 subjects in the AG200 treatment group; 45 subjects in the AG200LE treatment group; and 33 subjects in the AG200-15 treatment group.

: Subjects enrolled were healthy adult women aged 18-45 years with a history of regular menstrual cycles (i.e., lasting between 21 and 35 days) and no disorders precluding hormonal contraceptive use.

Participant milestones

Participant milestones
Measure	AG200LE Transdermal Contraceptive Delivery System a 12.5 cm2 patch (Lot #27621) containing 2.17 LNG/1.28 EE mg (designed to deliver approximately: 0.075 LNG/0.015 EE mg/day).	AG200 Transdermal Contraceptive Delivery System a 12.5 cm2 patch (Lot #27620) containing 2.17 LNG/1.92 EE mg (designed to deliver approximately: 0.1 LNG/0.02 EE mg/day).	AG200-15 Transdermal Contraceptive System a 15 cm2 patch (Lot #27620) containing 2.60 LNG/2.30 EE mg (designed to deliver approximately: 0.12 LNG/0.025 EE mg/day).
Overall Study STARTED	45	45	33
Overall Study COMPLETED	41	41	25
Overall Study NOT COMPLETED	4	4	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AG200LE Transdermal Contraceptive Delivery System n=43 Participants a 12.5 cm2 patch (Lot #27621) containing 2.17 LNG/1.28 EE mg (designed to deliver approximately: 0.075 LNG/0.015 EE mg/day).	AG200 Transdermal Contraceptive Delivery System n=44 Participants a 12.5 cm2 patch (Lot #27620) containing 2.17 LNG/1.92 EE mg (designed to deliver approximately: 0.1 LNG/0.02 EE mg/day).	AG200-15 Transdermal Contraceptive System n=31 Participants a 15 cm2 patch (Lot #27620) containing 2.60 LNG/2.30 EE mg (designed to deliver approximately: 0.12 LNG/0.025 EE mg/day).	Total n=118 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	44 Participants n=7 Participants	31 Participants n=5 Participants	118 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	31.7 years STANDARD_DEVIATION 7.4 • n=5 Participants	31 years STANDARD_DEVIATION 6.9 • n=7 Participants	32.1 years STANDARD_DEVIATION 7.8 • n=5 Participants	31.6 years STANDARD_DEVIATION 7.3 • n=4 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	44 Participants n=7 Participants	31 Participants n=5 Participants	118 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	43 Participants n=5 Participants	44 Participants n=7 Participants	31 Participants n=5 Participants	118 Participants n=4 Participants

PRIMARY outcome

Timeframe: 3 months

Population: ITT, perfect compliance, complete progesterone, verifiable compliance

Outcome measures

Outcome measures
Measure	AG200LE n=104 Total number of cycles a 12.5 cm2 patch (Lot #27621) containing 2.17 LNG/1.28 EE mg (designed to deliver approximately: 0.075 LNG/0.015 EE mg/day).	AG200 n=92 Total number of cycles a 12.5 cm2 patch (Lot #27620) containing 2.17 LNG/1.92 EE mg (designed to deliver approximately: 0.1 LNG/0.02 EE mg/day).	AG200-15 n=61 Total number of cycles a 15 cm2 patch (Lot #27620) containing 2.60 LNG/2.30 EE mg (designed to deliver approximately: 0.12 LNG/0.025 EE mg/day).
Ovulation Suppression in Three Treatment Groups Over 3 Cycles ITT, perfect compliance	36.5 %of cycles with possible ovulation	20.7 %of cycles with possible ovulation	11.5 %of cycles with possible ovulation
Ovulation Suppression in Three Treatment Groups Over 3 Cycles Complete progesterone, perfect compliance	36.9 %of cycles with possible ovulation	20.7 %of cycles with possible ovulation	11.7 %of cycles with possible ovulation
Ovulation Suppression in Three Treatment Groups Over 3 Cycles ITT, verifiable compliance	32.5 %of cycles with possible ovulation	14.9 %of cycles with possible ovulation	12.0 %of cycles with possible ovulation
Ovulation Suppression in Three Treatment Groups Over 3 Cycles Complete progesterone, verifiable compliance	32.5 %of cycles with possible ovulation	14.9 %of cycles with possible ovulation	12.0 %of cycles with possible ovulation

PRIMARY outcome

Timeframe: 3 months

Population: ITT population

The incidence of breakthrough bleeding (BTB) and/or spotting (S) episodes in Cycle 3 for ITT cycles. A BTB/S episode was defined as any number of days with BTB and/or BTS preceded and followed by at least 2 bleeding-free days.

Outcome measures

Outcome measures
Measure	AG200LE n=42 Participants a 12.5 cm2 patch (Lot #27621) containing 2.17 LNG/1.28 EE mg (designed to deliver approximately: 0.075 LNG/0.015 EE mg/day).	AG200 n=42 Participants a 12.5 cm2 patch (Lot #27620) containing 2.17 LNG/1.92 EE mg (designed to deliver approximately: 0.1 LNG/0.02 EE mg/day).	AG200-15 n=27 Participants a 15 cm2 patch (Lot #27620) containing 2.60 LNG/2.30 EE mg (designed to deliver approximately: 0.12 LNG/0.025 EE mg/day).
Cycle Control	0.29 number of episodes Standard Deviation 0.46	0.29 number of episodes Standard Deviation 0.46	0.15 number of episodes Standard Deviation 0.36

Adverse Events

AG200LE

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

AG200

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

AG200-15

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AG200LE n=43 participants at risk a 12.5 cm2 patch (Lot #27621) containing 2.17 LNG/1.28 EE mg (designed to deliver approximately: 0.075 LNG/0.015 EE mg/day).	AG200 n=44 participants at risk a 12.5 cm2 patch (Lot #27620) containing 2.17 LNG/1.92 EE mg (designed to deliver approximately: 0.1 LNG/0.02 EE mg/day).	AG200-15 n=31 participants at risk a 15 cm2 patch (Lot #27620) containing 2.60 LNG/2.30 EE mg (designed to deliver approximately: 0.12 LNG/0.025 EE mg/day).
Gastrointestinal disorders Gastrointestinal disorders	4.7% 2/43 • Number of events 2 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	13.6% 6/44 • Number of events 6 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	16.1% 5/31 • Number of events 5 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.
General disorders General disorders and administration site conditions	4.7% 2/43 • Number of events 2 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	11.4% 5/44 • Number of events 5 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	16.1% 5/31 • Number of events 5 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.
Immune system disorders Immune system disorders	0.00% 0/43 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	4.5% 2/44 • Number of events 2 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	0.00% 0/31 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.
Infections and infestations Infections and infestations	9.3% 4/43 • Number of events 4 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	4.5% 2/44 • Number of events 2 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	19.4% 6/31 • Number of events 6 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.
Investigations Investigations	4.7% 2/43 • Number of events 2 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	6.8% 3/44 • Number of events 3 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	3.2% 1/31 • Number of events 1 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	0.00% 0/43 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	6.8% 3/44 • Number of events 3 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	3.2% 1/31 • Number of events 1 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.
Nervous system disorders Nervous system disorders	2.3% 1/43 • Number of events 1 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	11.4% 5/44 • Number of events 5 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	9.7% 3/31 • Number of events 3 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.
Renal and urinary disorders Renal and urinary disorders	2.3% 1/43 • Number of events 1 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	0.00% 0/44 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	6.5% 2/31 • Number of events 2 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.
Reproductive system and breast disorders Reproductive system and breast disorders	7.0% 3/43 • Number of events 3 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	13.6% 6/44 • Number of events 6 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	19.4% 6/31 • Number of events 6 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	11.6% 5/43 • Number of events 5 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	13.6% 6/44 • Number of events 6 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	12.9% 4/31 • Number of events 4 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	9.3% 4/43 • Number of events 4 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	13.6% 6/44 • Number of events 6 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	19.4% 6/31 • Number of events 6 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.
Vascular disorders Vascular disorders	0.00% 0/43 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	2.3% 1/44 • Number of events 1 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.	6.5% 2/31 • Number of events 2 Adverse Events were analyzed for the Safety population. Adverse Events analyzed are based on Organ System class only.

Additional Information

Joseph Chiodo III, Senior Medical Director

Agile Therapeutics

Phone: 609-683-1880

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All publications must be reviewed and approved by sponsor
Publication restrictions are in place

Restriction type: OTHER