Trial · NCT00544882

A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021

NCT00544882, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2014-06-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021. Trials, record NCT00544882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00544882

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021
NCT number: NCT00544882
Status: Completed
Phases: Phase 3
Enrollment: 61 participants, actual
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Conditions: Healthy
Interventions: DR-1021, Mircette®, Kariva®
First posted: 2007-10-16
Last updated: 2021-11-18
Results first posted: 2014-06-10

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Serum Estradiol Levels by Cycle Day	Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.	Levels of estradiol were measured throughout the study from blood samples.
Primary	Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day	Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.	Levels of follicle stimulating hormone were measured throughout the study from blood samples.
Primary	Serum Inhibin-B Levels by Cycle Day	Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.	Levels of inhibin-B were measured throughout the study from blood samples.
Secondary	Percentage of Follicles Greater Than 5 mm in Diameter	Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.	Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point).
Secondary	Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size	Cycle 2, Days 1-20 and Cycle 2, Days 21-28	The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound.
Secondary	Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21	The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal \[Day 22 to Day 28 of each cycle\]) bleeding or spotting was derived from participant diaries.
Secondary	Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21	The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal \[Day 22 to Day 28 of each cycle\]) bleeding or spotting was derived from participant diaries.
Secondary	Number of Days of Bleeding During Unscheduled and Scheduled Study Periods	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21	The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal \[Day 22 to Day 28 of each cycle\]) bleeding (not including spotting) was derived from participant diaries.
Secondary	Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21	The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal \[Day 22 to Day 28 of each cycle\]) bleeding (not including spotting) was derived from participant diaries.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Serum Estradiol Levels by Cycle Day	Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.	Intent-to-treat population with available data at each time point (as indicated by n).	pg/mL	MEDIAN
SECONDARY	Percentage of Follicles Greater Than 5 mm in Diameter	Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.	Intent-to-treat	percentage of follicles	NUMBER
PRIMARY	Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day	Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.	Intent-to-treat population with available data at each time point (as indicated by n).	mIU/mL	MEDIAN
PRIMARY	Serum Inhibin-B Levels by Cycle Day	Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.	Intent-to-treat population with available data at each time point (as indicated by n).	pg/mL	MEDIAN
SECONDARY	Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size	Cycle 2, Days 1-20 and Cycle 2, Days 21-28	Intent-to-treat population with available data.	mm	MEAN
SECONDARY	Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21	Intent-to-treat	days	MEAN
SECONDARY	Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21	Intent-to-treat	percentage of participants	NUMBER
SECONDARY	Number of Days of Bleeding During Unscheduled and Scheduled Study Periods	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21	Intent-to-treat	days	MEAN
SECONDARY	Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods	Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21	Intent-to-treat	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group122

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Serum Estradiol Levels by Cycle Day	DR-1021	Cycle 2 - Day 2 (n=28, 28)	47.00	Full Range 15.0 to 361.0	pg/mL
Serum Estradiol Levels by Cycle Day	Mircette	Cycle 2 - Day 2 (n=28, 28)	51.50	Full Range 6.0 to 322.0	pg/mL
Serum Estradiol Levels by Cycle Day	DR-1021	Cycle 2 - Day 4 (n=28, 28)	62.50	Full Range 1.0 to 613.0	pg/mL
Serum Estradiol Levels by Cycle Day	Mircette	Cycle 2 - Day 4 (n=28, 28)	34.50	Full Range 1.0 to 423.0	pg/mL
Serum Estradiol Levels by Cycle Day	DR-1021	Cycle 2 - Day 6 (n=27, 27)	43.00	Full Range 1.0 to 579.0	pg/mL
Serum Estradiol Levels by Cycle Day	Mircette	Cycle 2 - Day 6 (n=27, 27)	29.00	Full Range 1.0 to 274.0	pg/mL
Serum Estradiol Levels by Cycle Day	DR-1021	Cycle 2 - Days 19-20 (n=26, 28)	19.00	Full Range 1.0 to 152.0	pg/mL
Serum Estradiol Levels by Cycle Day	Mircette	Cycle 2 - Days 19-20 (n=26, 28)	20.50	Full Range 1.0 to 327.0	pg/mL
Serum Estradiol Levels by Cycle Day	DR-1021	Cycle 2 - Day 23 (n=27, 28)	24.00	Full Range 1.0 to 204.0	pg/mL
Serum Estradiol Levels by Cycle Day	Mircette	Cycle 2 - Day 23 (n=27, 28)	19.00	Full Range 1.0 to 159.0	pg/mL

1 to 10 of 122Source ClinicalTrials.gov

See all 122 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Cycle 1: Run-in Cycle	STARTED	Run-In Cycle - All Enrolled	61
Cycle 1: Run-in Cycle	STARTED	DR-1021	0
Cycle 1: Run-in Cycle	STARTED	Mircette	0
Cycle 1: Run-in Cycle	COMPLETED	Run-In Cycle - All Enrolled	58
Cycle 1: Run-in Cycle	COMPLETED	DR-1021	0
Cycle 1: Run-in Cycle	COMPLETED	Mircette	0
Cycle 1: Run-in Cycle	NOT COMPLETED	Run-In Cycle - All Enrolled	3
Cycle 1: Run-in Cycle	NOT COMPLETED	DR-1021	0
Cycle 1: Run-in Cycle	NOT COMPLETED	Mircette	0
Cycle 2: Randomized Treatment Cycle	STARTED	Run-In Cycle - All Enrolled	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	DR-1021	0	28	0
other	Nasopharyngitis	Infections and infestations	Mircette	2	28	2
other	Upper respiratory tract infection	Infections and infestations	DR-1021	1	28	1
other	Upper respiratory tract infection	Infections and infestations	Mircette	4	28	4
other	Urinary tract infection	Infections and infestations	DR-1021	2	28	2
other	Urinary tract infection	Infections and infestations	Mircette	0	28	0
other	Back pain	Musculoskeletal and connective tissue disorders	DR-1021	2	28	2
other	Back pain	Musculoskeletal and connective tissue disorders	Mircette	0	28	0
other	Headache	Nervous system disorders	DR-1021	0	28	0
other	Headache	Nervous system disorders	Mircette	2	28	2

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DR-1021
Total, all-cause mortality	Mircette
Total, other adverse events	DR-1021	7	28
Total, other adverse events	Mircette	7	28
Total, serious adverse events	DR-1021	0	28
Total, serious adverse events	Mircette	1	28

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
DR-1021 vs Mircette: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00544882

GET https://conductscience.org/api/trials/v1/NCT00544882/results?page=2

API reference For AI assistants