Clinical trial · Interventional
Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women
Metabolic Effects of Multiple Therapies in Polycystic Ovary Syndrome (PCOS) Women
NCT00842140CI-TRIAL-00003693completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study to assess early markers of cardiovascular disease in women with polycystic ovary syndrome in use of oral contraceptive containing ethynilestradiol and chlormadinone acetate alone or associated with Spironolactone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral contraceptive | Drug | — | UNRESOLVED |
| Oral contraceptive plus metformin | Drug | — | UNRESOLVED |
| Oral contraceptive plus spironolactone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- This group will receive an oral contraceptive containing 0,03mg ethynylestradiol and 2mg chlormadinone acetate
- interventionNames
- Drug: oral contraceptive
- type
- EXPERIMENTAL
- label
- 2
- description
- The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 100 mg spironolactone. One pill each once a day for twelve months.
- interventionNames
- Drug: Oral contraceptive plus spironolactone
- type
- EXPERIMENTAL
- label
- 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * age between 18 and 35 years * diagnosis of PCOS by Rotterdam Consensus Exclusion Criteria: * smoking, alcoholism, drug addiction; * current pregnancy; * current or previous use (up to two months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives; * current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant, or intrauterine device); * antiandrogenic or hypoglycemic drugs, anti-inflammatory drugs, or statins; * presence of systemic diseases (DM2, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia); * personal history of arterial or venous thrombosis; chronic or acute inflammatory processes; * puerperium of 12 weeks or less
References
Publications (0)
Data not yet available
No reference posted for this study.